IA #89-07, 8/8/01, "DETENTION WITHOUT PHYSICAL EXAMINATION OF GYNECOLOGICAL
DEVICES MANUFACTURED BY LEIBAN INTERNATIONAL"
NOTE: This revision is being issued to revise the alert into the current
format and terminology. Changes are bracketed by asterisks (***).
TYPE OF
ALERT: *** Detention Without Physical Examination (DWPE)***
NOTE: This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or products(s)
at issue. It does not create or confer any rights for or on any
person, and does not operate to bind FDA or the public.
PRODUCT: Autoexpandable and Discardable Speculum for Gynecological Use
Models: Small #2, Medium #3, Large #4
PRODUCT
CODE: *** 85H[][][][] ***
PROBLEM: *** Lacks adequate directions for use ***
PAF: *** LBL (Labeling) ***
PAC: *** 82008 ***
COUNTRY: Argentina (AR)
MANUFACTURER/
SHIPPER: Lebian International, S.R.L.
La Pax 1071
Rosario, Argentina
FEI# 12587
IMPORTER'S
I.D.#: ^
^
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3), in that it appears that its labeling does not
bear adequate directions for use [Misbranding, Section
502(f)(1)]."
OASIS CHARGE
CODE: DIRECTIONS
RECOMMENDING
OFFICE: CDRH, OC, (HFZ-323)
REASON FOR
ALERT: The labeling on the device lacks the information specified in 21
CFR 801.109. Therefore, the article is not exempt from the
requirement in Section 502(f)(1) that it labeling bear adequate
directions for use.
Because of the unique autoexpandable feature of the speculum and
the lack of specific and detailed instructions, the labeling, as
provided, is inadequate. The device is unusual and, as such, the
method and idiosyncrasies of its use will not be completely
obvious to the clinician. Detailed instructions and caution
statements are necessary to eliminate the potential hazard to
health. CDRH has informed the law firm representing the
manufacturer that the devices will be denied entry into the United
States.
GUIDANCE: Districts may detain without physical examination the devices from
the firm identified in this alert.
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology,
contact the Division of Field Science at (301) 827-7605.
PRIORITIZATION
GUIDANCE: N/A
FOI: Information designated between ^ ^< requires purging.
KEYWORDS: Speculum, OBGYN, Gynecology,
PREPARED
BY: Ted Poplawski, DIOP, 301-443-6553
DATE LOADED
INTO FIARS:
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