CLASS II Device recall · Reported 27 Jun 2012 · FDA Enforcement Report

seprafilm¿ Single Site Adhesion Barrier Re recalled by Genzyme

Genzyme is recalling seprafilm¿ Single Site Adhesion Barrier Re, distributed nationwide in the US. The recall was initiated on 13 Jun 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number: 11NP685 . Exp 2014- 11

Quantity recalled1285 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1856-2012
FDA event ID: 62127
Recalling firm: Genzyme, Framingham, MA
Classification: Class II
Status: Terminated
Recall initiated: 13 Jun 2012
FDA classified: 21 Jun 2012
Reported: 27 Jun 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

13 Jun 2012	Recall initiated by company
21 Jun 2012	Classified by FDA	+8 days
27 Jun 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sterility of product may be compromised due to packaging defect

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.

Where it was distributed

Worldwide Distribution - US (nationwide) and the country of S. Korea

Nationwide

Questions about this recall

Why was it recalled?

Sterility of product may be compromised due to packaging defect

Which lots are affected?

Lot number: 11NP685 . Exp 2014- 11

Where was it sold?

Worldwide Distribution - US (nationwide) and the country of S. Korea

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 62127

This product is part of a recall event; the main page for the event is seprafilm¿ Procedure Pack Adhesion Barrier Re recalled by Genzyme.

Reported	Class	Recall	Company	Reason	Where
27 Jun 2012	CLASS II	seprafilm¿ Procedure Pack Adhesion Barrier Re recalled by Genzyme	Genzyme	Sterility	Nationwide

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