Letter -Clinipad
[U.S. Food and
Drug  Administration]

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This is the retyped text of a letter from Clinipad Corporation. Contact the company for a copy of any referenced enclosures.

Clinipad Corporation
URGENT -- DRUG RECALL
List of "Sterile" Products
     
Clinipad Reorder Code NDC Number Product Description
0110 NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110B3 NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110BS NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110CRB NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110H NDC 00839-8072-06 Moore Medical Corp. Alcohol Prep Pad 70% Isopropyl Alcohol Medium 2 Ply, Reoroder No. 30839 Box/200 Reorder No. 08481 Box/100
0110M NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110R NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110T NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110TA NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0250B NDC 19154-1245-8 CLINIPAD Alcohol Prep, Antiseptic
0250R NDC 19154-1245-8 CLINIPAD Alcohol Prep, Antiseptic
0310S-B NDC 19154-1247-2 CLINIPAD Acetone Alcohol Prep, 1 Prep Pad
0510 NDC 19154-1245-7 Steri Wipe 1 Alcohol Swab
0510B NDC 19154-1245-7 Steri Wipe 1 Alcohol Swab
0510-BT NDC 19154-1245-7 Steri Wipe 1 Alcohol Swab
0610ER-RAU n/a Rauscher Alcotupf Alkoholtupfer Tampons alcoolises Alcohol Swabs REF ALKT
1231S-B NDC 19154-1231-2 CLINISWAB Compound Benzoin Tincture Topical Protectant, 1 Saturated Swabstick
HK1231S NDC 19154-1231-2 CLINISWAB Compound Benzoin Tincture Topical Protectant, 1 Saturated Swabstick
1233S-B n/a CLINIGUARD Protective Dressing, 1 Saturated Swabstick
1241S-B NDC 19154-1241-2 CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic, 1 Saturated Swabstick
1243S-B NDC 19154-1243-3 CLINISWAB Iodine Tincture, 2% U.S.P. Topical Anti-Infective, 1 Saturated Swabstick
1244S-B NDC 19154-1242-7 CLINISWAB Iodophor PVP Scrub Povidone Iodine USP 3 Saturated Swabsticks
1245S-B NDC 19154-1245-0 CLINISWAB Isopropyl Alcohol Antiseptic, 3 Saturated Swabsticks
1247S-B NDC 19154-1247-3 CLINISWAB Acetone Alcohol Topical Anti-Infective, 1 Saturated Swabstick
1248S-B NDC 19154-1247-5 CLINISWAB Acetone Alcohol Topical Anti-Infective, 3 Saturated Swabsticks
1251S-B NDC 19154-1245-9 CLINISWAB Isopropyl Alcohol Antiseptic, 1 Saturated Swabstick
1261S NDC 19154-1241-2 CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic, 1 Saturated Swabstick
1262S NDC 19154-1242-9 CLINISWAB Iodophor PVP Scrub, Povidone Iodine USP, Antiseptic, 1 Saturated Swabstick
1291S-B NDC 19154-1241-3 CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic, 3 Saturated Swabsticks
1291SK NDC 19154-1241-0 CLINISWAB Iodophor PVP Antiseptic Cleanser, Povidone Iodine 10% USP, 3 Saturated Swabsticks
1291SKB NDC 19154-1241-0 CLINISWAB Iodophor PVP Antiseptic Cleanser, Povidone Iodine 10% USP, 3 Saturated Swabsticks
372201 NDC 19154-1462-1 EZ PREP 220 Povidone Iodine (Minimum Available Iodine 0.5%) 2-8"SpongeSticks
3941S-B NDC 19154-1241-4 CLINIPAD IODOPHOR-PVP, Povidone-Iodine USP,Titratable Iodine 1%, Solution, Antiseptic 1 fl.oz (30ml.)
3941S-BC NDC 19154-1241-4 CLINIPAD IODOPHOR-PVP, Povidone-Iodine USP,Titratable Iodine 1%, Solution, Antiseptic 1 fl.oz (30ml.)
3943S-B NDC 19154-1241-5 CLINIDINE Povidone Iodine 1% USP Solution Topical Anti-Infective, 1 fl. oz (30 ml)
3944S-B NDC 19154-1241-7 CLINIDINE Povidone Iodine 10% USP Solution Antiseptic Cleanser, 3/4 fl. oz (21ml)
4339S-B NDC 19154-4341-4 CLINIDINE OINTMENT Povidone Iodine USP Titratable Iodine 1% Antiseptic Germicide Net WT.033 oz. (1.0g)
4339SC NDC 19154-4341-4 CLINIDINE OINTMENT Povidone Iodine USP Titratable Iodine 1% Antiseptic Germicide Net WT.033 oz. (1.0g)
8133S-B n/a CLINIGUARD Protective Dressing Prep, 1 Prep Pad
90110 NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
9153S-B NDC 19154-1241-1 CLINIPAD Iodophor PVP Povidone Iodine USP 1 Prep Pad
9153-SBD NDC 19154-1241-1 CLINIPAD Iodophor PVP Povidone Iodine USP 1 Prep Pad
93461 NDC 19154-1245-7 Steri Wipe 1 Alcohol Swab
99510 NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
99512 NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
99529 n/a Cooper Instrument Corporation Antibacterial Probe Wipes Single Use Packet
HK0110 NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
HK0110H NDC 00839-8072-06 Moore Medical Corp. Alcohol Prep Pad 70% Isopropyl Alcohol Medium 2 Ply, Reoroder No. 30839 Box/200 Reorder No. 08481 Box/100
HK0310S NDC 19154-1247-2 CLINIPAD Acetone Alcohol Prep, 1 Prep Pad
HK1233S n/a CLINIGUARD Protective Dressing, 1 Saturated Swabstick
HK1241S NDC 19154-1241-2 CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic, 1 Saturated Swabstick
HK1243S NDC 19154-1243-3 CLINISWAB Iodine Tincture, 2% U.S.P. Topical Anti-Infective, 1 Saturated Swabstick
HK1244S NDC 19154-1242-7 CLINISWAB Iodophor-PVP Scrub Povidone Iodine U.S.P. Antiseptic, 3 Saturated Swabsticks
HK1245S NDC 19154-1245-0 CLINISWAB Isopropyl Alcohol Antiseptic, 3 Saturated Swabsticks
HK1247S NDC 19154-1247-3 CLINISWAB Acetone Alcohol Topical Anti-Infective, 1 Saturated Sawbstick
HK1248S NDC 19154-1247-5 CLINISWAB Acetone Alcohol Topical Anti-Infective, 3 Saturated Sawbstick
HK1251S NDC 19154-1245-9 CLINISWAB Isopropyl Alcohol Antiseptic, 1 Saturated Swabstick
HK1291S NDC 19154-1241-3 CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic, 3 Saturated Swabsticks
HK2490S NDC 19154-9152-6 CLINIPAD Iodophor, Poloxamer-Iodine Complex, 3 Towelettes, Antiseptic
HK3925S NDC 19154-1245-5 CLINIPAD Isopropyl Alcohol 70% Antiseptic, 1 fl oz. (30 ml.)
HK3941S NDC 19154-1241-4 CLINIPAD IODOPHOR-PVP, Povidone-Iodine USP,Titratable Iodine 1%, Solution, Antiseptic 1 fl.oz (30ml.)
HK4339S NDC 19154-4341-4 CLINIDINE OINTMENT Povidone Iodine USP Titratable Iodine 1% Antiseptic Germicide Net WT.033 oz. (1.0g)
HK8133S n/a CLINIGUARD Protective Dressing Prep, 1 Prep Pad
HK9151S NDC 19154-1241-9 CLINIPAD Snapsule PVP Iodine Solution 10% USP Swab Applicator Net 0.67 ml Product No.9151S
HK9153S NDC 19154-1241-1 CLINIPAD Iodophor PVP Povidone Iodine USP 1 Prep Pad
Clinipad Corporation
URGENT -- DRUG RECALL
List of "Sterile" Products
Clinipad Reorder Code NDC Number Product Description
0110 NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110B3 NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110BS NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110CRB NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110H NDC 00839-8072-06 Moore Medical Corp. Alcohol Prep Pad 70% Isopropyl Alcohol Medium 2 Ply, Reoroder No. 30839 Box/200 Reorder No. 08481 Box/100
0110M NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110R NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110T NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0110TA NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
0250B NDC 19154-1245-8 CLINIPAD Alcohol Prep, Antiseptic
0250R NDC 19154-1245-8 CLINIPAD Alcohol Prep, Antiseptic
0310S-B NDC 19154-1247-2 CLINIPAD Acetone Alcohol Prep, 1 Prep Pad
0510 NDC 19154-1245-7 Steri Wipe 1 Alcohol Swab
0510B NDC 19154-1245-7 Steri Wipe 1 Alcohol Swab
0510-BT NDC 19154-1245-7 Steri Wipe 1 Alcohol Swab
0610ER-RAU n/a Rauscher Alcotupf Alkoholtupfer Tampons alcoolises Alcohol Swabs REF ALKT
1231S-B NDC 19154-1231-2 CLINISWAB Compound Benzoin Tincture Topical Protectant, 1 Saturated Swabstick
HK1231S NDC 19154-1231-2 CLINISWAB Compound Benzoin Tincture Topical Protectant, 1 Saturated Swabstick
1233S-B n/a CLINIGUARD Protective Dressing, 1 Saturated Swabstick
1241S-B NDC 19154-1241-2 CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic, 1 Saturated Swabstick
1243S-B NDC 19154-1243-3 CLINISWAB Iodine Tincture, 2% U.S.P. Topical Anti-Infective, 1 Saturated Swabstick
1244S-B NDC 19154-1242-7 CLINISWAB Iodophor PVP Scrub Povidone Iodine USP 3 Saturated Swabsticks
1245S-B NDC 19154-1245-0 CLINISWAB Isopropyl Alcohol Antiseptic, 3 Saturated Swabsticks
1247S-B NDC 19154-1247-3 CLINISWAB Acetone Alcohol Topical Anti-Infective, 1 Saturated Swabstick
1248S-B NDC 19154-1247-5 CLINISWAB Acetone Alcohol Topical Anti-Infective, 3 Saturated Swabsticks
1251S-B NDC 19154-1245-9 CLINISWAB Isopropyl Alcohol Antiseptic, 1 Saturated Swabstick
1261S NDC 19154-1241-2 CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic, 1 Saturated Swabstick
1262S NDC 19154-1242-9 CLINISWAB Iodophor PVP Scrub, Povidone Iodine USP, Antiseptic, 1 Saturated Swabstick
1291S-B NDC 19154-1241-3 CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic, 3 Saturated Swabsticks
1291SK NDC 19154-1241-0 CLINISWAB Iodophor PVP Antiseptic Cleanser, Povidone Iodine 10% USP, 3 Saturated Swabsticks
1291SKB NDC 19154-1241-0 CLINISWAB Iodophor PVP Antiseptic Cleanser, Povidone Iodine 10% USP, 3 Saturated Swabsticks
372201 NDC 19154-1462-1 EZ PREP 220 Povidone Iodine (Minimum Available Iodine 0.5%) 2-8"SpongeSticks
3941S-B NDC 19154-1241-4 CLINIPAD IODOPHOR-PVP, Povidone-Iodine USP,Titratable Iodine 1%, Solution, Antiseptic 1 fl.oz (30ml.)
3941S-BC NDC 19154-1241-4 CLINIPAD IODOPHOR-PVP, Povidone-Iodine USP,Titratable Iodine 1%, Solution, Antiseptic 1 fl.oz (30ml.)
3943S-B NDC 19154-1241-5 CLINIDINE Povidone Iodine 1% USP Solution Topical Anti-Infective, 1 fl. oz (30 ml)
3944S-B NDC 19154-1241-7 CLINIDINE Povidone Iodine 10% USP Solution Antiseptic Cleanser, 3/4 fl. oz (21ml)
4339S-B NDC 19154-4341-4 CLINIDINE OINTMENT Povidone Iodine USP Titratable Iodine 1% Antiseptic Germicide Net WT.033 oz. (1.0g)
4339SC NDC 19154-4341-4 CLINIDINE OINTMENT Povidone Iodine USP Titratable Iodine 1% Antiseptic Germicide Net WT.033 oz. (1.0g)
8133S-B n/a CLINIGUARD Protective Dressing Prep, 1 Prep Pad
90110 NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
9153S-B NDC 19154-1241-1 CLINIPAD Iodophor PVP Povidone Iodine USP 1 Prep Pad
9153-SBD NDC 19154-1241-1 CLINIPAD Iodophor PVP Povidone Iodine USP 1 Prep Pad
93461 NDC 19154-1245-7 Steri Wipe 1 Alcohol Swab
99510 NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
99512 NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
99529 n/a Cooper Instrument Corporation Antibacterial Probe Wipes Single Use Packet
HK0110 NDC 19154-1245-3 CLINIPAD Alcohol Prep, Antiseptic
HK0110H NDC 00839-8072-06 Moore Medical Corp. Alcohol Prep Pad 70% Isopropyl Alcohol Medium 2 Ply, Reoroder No. 30839 Box/200 Reorder No. 08481 Box/100
HK0310S NDC 19154-1247-2 CLINIPAD Acetone Alcohol Prep, 1 Prep Pad
HK1233S n/a CLINIGUARD Protective Dressing, 1 Saturated Swabstick
HK1241S NDC 19154-1241-2 CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic, 1 Saturated Swabstick
HK1243S NDC 19154-1243-3 CLINISWAB Iodine Tincture, 2% U.S.P. Topical Anti-Infective, 1 Saturated Swabstick
HK1244S NDC 19154-1242-7 CLINISWAB Iodophor-PVP Scrub Povidone Iodine U.S.P. Antiseptic, 3 Saturated Swabsticks
HK1245S NDC 19154-1245-0 CLINISWAB Isopropyl Alcohol Antiseptic, 3 Saturated Swabsticks
HK1247S NDC 19154-1247-3 CLINISWAB Acetone Alcohol Topical Anti-Infective, 1 Saturated Sawbstick
HK1248S NDC 19154-1247-5 CLINISWAB Acetone Alcohol Topical Anti-Infective, 3 Saturated Sawbstick
HK1251S NDC 19154-1245-9 CLINISWAB Isopropyl Alcohol Antiseptic, 1 Saturated Swabstick
HK1291S NDC 19154-1241-3 CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic, 3 Saturated Swabsticks
HK2490S NDC 19154-9152-6 CLINIPAD Iodophor, Poloxamer-Iodine Complex, 3 Towelettes, Antiseptic
HK3925S NDC 19154-1245-5 CLINIPAD Isopropyl Alcohol 70% Antiseptic, 1 fl oz. (30 ml.)
HK3941S NDC 19154-1241-4 CLINIPAD IODOPHOR-PVP, Povidone-Iodine USP,Titratable Iodine 1%, Solution, Antiseptic 1 fl.oz (30ml.)
HK4339S NDC 19154-4341-4 CLINIDINE OINTMENT Povidone Iodine USP Titratable Iodine 1% Antiseptic Germicide Net WT.033 oz. (1.0g)
HK8133S n/a CLINIGUARD Protective Dressing Prep, 1 Prep Pad
HK9151S NDC 19154-1241-9 CLINIPAD Snapsule PVP Iodine Solution 10% USP Swab Applicator Net 0.67 ml Product No.9151S
HK9153S NDC 19154-1241-1 CLINIPAD Iodophor PVP Povidone Iodine USP 1 Prep Pad

 
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