Medical Material Quality Control Message
MMQC-15-1609
Message Number: |
MMQC-15-1609 |
Released On: |
12-AUG-15 |
Message Class: |
Unclassified |
Material Type: |
Vaccine |
MMQC\MMI Reference: |
FDA Recall Reference: |
ECRI Reference: |
A24791 |
DLA Reference: |
MFG Release Date: |
22-JUL-2015 |
Subject:
Vascular Loop / CareFusion
Reason / Information:
CareFusion issued an Urgent Product Recall for the following materiel (See Image on Message under Additional Documentation/Attachment). Reason: Due to notification from the manufacturing facility that the sterile pouch heat seal may potentially come open during transport.
Disposition / Instructions:
Customers should take the following Immediate Actions in an expeditious manner:
--Immediately quarantine all affected materiel.
--Immediately complete and return to CareFusion a Recall Response Form by fax to 312-949-9491 or by email at GMD-GLB-VMfieldactions@carefusion.com.
--When destroying affected materiel, follow the local facilities disposal protocol/procedure. If customer's facility policy does not allow destruction, contact CareFusion Customer Support at 800-323-9008, option #5, Monday through Friday, 8 a.m. to 5 p.m., Eastern Time for return options.
--If customers purchased materiel direct through CareFusion and wish to obtain credit for destroyed materiel, contact CareFusion Customer Support at 800-323-9088, option #1, Monday through Friday, 8 a.m. to 5 p.m., Central Time and indicate CareFusion Vascular Loop Recall.
If customers have any clinical questions related to this recall, contact Anna Wehrheim, RN, Manager of Medical Specialties at 847-362-8063 or via email at anna.wehrheim@carefusion.com.
Item Information:
NSN (FSC-NIIN): |
6515 - 013357916 |
PartNo: |
CH111 |
Nomenclature: |
VASCULAR LOOP |
UI: |
BX |
Manufacturer: |
CAREFUSION |
Distributor: |
LOT / SN:
031715-3418
050815-3513
052115-3540
NOTE 1:
Lot #031715-3418 - Expiration Date - 17 March 2019; Lot #050815-3513 - Expiration Date - 08 May 2019; Lot #052115-3540 - Expiration Date - 21 May 2019
NSN (FSC-NIIN): |
6515 - NS1 |
PartNo: |
CH112 |
Nomenclature: |
VASCULAR LOOP |
UI: |
BX |
Manufacturer: |
CAREFUSION |
Distributor: |
LOT / SN:
033015-3435
052115-3542
NOTE 1:
Lot #033015-3435 - Expiration Date - 30 March 2019; Lot #052115-3542 - Expiration Date - 21 May 2019
NSN (FSC-NIIN): |
6515 - NS2 |
PartNo: |
CH113 |
Nomenclature: |
VASCULAR LOOP |
UI: |
BX |
Manufacturer: |
CAREFUSION |
Distributor: |
LOT / SN:
031615-3417
050815-3514
052115-3543
NOTE 1:
Lot #031615-3417 - Expiration Date - 16 March 2019; Lot #050815-3514 - Expiration Date - 08 May 2019; Lot #052115-3543 - Expiration Date- 21 May 2019
NSN (FSC-NIIN): |
6515 - 011656718 |
PartNo: |
CH114 |
Nomenclature: |
VASCULAR LOOP |
UI: |
BX |
Manufacturer: |
CAREFUSION |
Distributor: |
LOT / SN:
033015-3436
050815-3515
060915-3578
NOTE 1:
Lot #033015-3436 - Expiration Date - 30 March 2019; Lot #050815-3515 - Expiration Date - 08 May 2019; Lot #060915-3578 - Expiration Date - 09 June 2019
ARMY Unit Assemblages
UA      NIIN           NOMENCLATURE
1366   001050123   RSL CSH 84 BED CORP
9114   015295183   MEDICAL SET BRIGHTSTA
A301   012472966   MMS OPER RM DEP LSHL
A380   012481023   MMS MEDSUP 60BED LSHL
A381   012476575   MMS MEDSUP 200BED CSH
A480   013250095   MMS MED SUP 516 BED
A481   013250097   MMS MED SUP 476 BED
F301   015319596   FMS OPERATING RO
K383   013249292   MMS MED SUP CMBT SPT
L301   012994218   MMS OPER RM DEPMEDS\L
L320   012994258   MMS EENT AUG DEPMED\L
L380   012994215   MMS MD SUP MASH\L
L381   012994216   MMS MED SUP CSH\L
L382   012994217   MMS MD SUP EVAC HSP\L
L483   012998078   MEDICAL MATERIEL SE
M381   013320160   MMS MED SUP CSH AR/M
M480   013464824   MMS MEDSUP FLD MF2K/M
M481   013464825   MMS MEDSUP GEN MF2K/M
M488   013320167   MMS MED SUP H 100B/M
M583   014495182   MMS MED SUP 84 BED CO
M783   014495624   MMS MED SUP 164BED CO
N301   015244460   MMS OPER RM DEPMEDS\N
N583   015299063   MMS MED SUP 84 B-2005
N783   015299040   MMS MED SUP 164B-2005
P301   015905787   MMS OR 2010
P583   016002237   MMS 84 BED CSH-2011
P783   016062838   MMS MED SUP 164B CSH-
Q301   016204806   MMS OPERATING ROOM
NSN (FSC-NIIN): |
6515 - NS3 |
PartNo: |
CH115 |
Nomenclature: |
VASCULAR LOOP |
UI: |
BX |
Manufacturer: |
CAREFUSION |
Distributor: |
LOT / SN:
041715-3478
NOTE 1:
Lot #041715-3478 - Expiration Date - 17 April 2019
NSN (FSC-NIIN): |
6515 - NS4 |
PartNo: |
CH116 |
Nomenclature: |
VASCULAR LOOP |
UI: |
BX |
Manufacturer: |
CAREFUSION |
Distributor: |
LOT / SN:
033015-3437
050815-3516
052215-3545
NOTE 1:
Lot #033015-3437 - Expiration Date - 30 March 2019; Lot #050815-3516 - Expiration Date - 08 May 2019; Lot #052215-3545 - Expiration Date - 21 May 2019
NSN (FSC-NIIN): |
6515 - 013548654 |
PartNo: |
CH118 |
Nomenclature: |
VASCULAR LOOP |
UI: |
BX |
Manufacturer: |
CAREFUSION |
Distributor: |
LOT / SN:
042015-3482
052115-3541
NOTE 1:
Lot #042015-3482 - Expiration Date - 20 April 2019; Lot #052115-3541 - Expiration Date - 21 May 2019
ARMY Unit Assemblages
UA      NIIN           NOMENCLATURE
A380   012481023   MMS MEDSUP 60BED LSHL
A381   012476575   MMS MEDSUP 200BED CSH
L301   012994218   MMS OPER RM DEPMEDS\L
L302   013003523   MMS CEN MAINTEN DEP\L
L380   012994215   MMS MD SUP MASH\L
L381   012994216   MMS MED SUP CSH\L
L382   012994217   MMS MD SUP EVAC HSP\L
L483   012998078   MEDICAL MATERIEL SE
M381   013320160   MMS MED SUP CSH AR/M
M488   013320167   MMS MED SUP H 100B/M
Service/Additional Instructions:
POC Contact Information:
ARMY:
Email: |
usarmy.detrick.medcom-usamma.mbx.doc@mail.mil |
Phone (COMM): |
301-619-4300 |
Phone (DSN): |
343-4300 |
Fax: |
301-619-4468 |
NAVY:
Email: |
usn.detrick.navmedlogcomftdmd.list.mmqc@mail.mil |
Phone (COMM): |
301-619-3085 |
Phone (DSN): |
343-3085 |
Fax: |
301-619-2473 |
US AIR FORCE:
Email: |
afmoa.sgalc@us.af.mil |
Phone (COMM): |
301-619-4170 |
Phone (DSN): |
343-4170 |
Fax: |
301-619-2557 |
USAMMC-E:
Email: |
usarmy.rheinland-pfalz.medcom-usammce.list.dtd-quality-assurance@mail.mil |
Phone (COMM): |
011-49-6331-86-7118/7181 |
Phone (DSN): |
495-7118 |
Fax: |
6218 |
Additional Message Recipients:
Please ensure dissemination of this information to the following:
Command Channels
Medical Log Officers
Medical Staff
Supply Officers
Supported Activities/Centers
Cardiology/Cardiac Catheterization Laboratory, Materials Management, OR/Surgery, Infection Control
Message Dissemination Authorization
AF Activities Will Take Action As Prescribed In AFI 41-209, Medical Logistics Support, Chapter 3. For MACOMS & NGB--This Msg Has Been Transmitted To All Designated Subordinate Medical Activities.
See Army Regulation (AR) 40-61, 28 January 2005, Chapter 4, and The Department Of The Army Supply Bulletin (SB 8-75-11) For Applicable Policies and Procedures.
DODD 5105.22 and DODD 6025.13
Additional Documentation / Attachments
MMQC-15-1609_1.pdf
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