Z-1856-2012Class II

seprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01

Name: Z-1856-2012 seprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01
Creator: Genzyme Corporation
Published: 2012-06-13
License: https://open.fda.gov/license/

Genzyme Corporation / initiated 2012-06-13 / Terminated / root cause: packaging

FDA source

Genzyme Corporation began a recall of seprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal... on 2012-06-13. FDA classified it as Class II and gives the reason as "Sterility of product may be compromised due to packaging defect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1856-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-13
Posted: 2012-06-21
Terminated: 2013-07-24
Recalling firm: Genzyme Corporation
Product: 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.
Product code: MCN Barrier, Absorbable, Adhesion
Reason for recall: Sterility of product may be compromised due to packaging defect
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Genzyme issued an Urgent: Medicatical Device Product Recall Notification Letter dated June 13, 2012 to all affected customers. Stericycle Expert Solutions, will be acting on behalf of Genzyme to coordinate notifications, communications, and logistics for returns of all product subject to this recall. The letter identified the affected products, problen and actions to be taken. Customers are requested to check their inventory and return all affected products per the instructions provided. Customers are instructed to complete the enclosed Business Reply Form and return via fax transmission to 866-912-2519. For questions call Stericycle at: 877- 473-7069.
Quantity in commerce: 1285 units
Distribution: Worldwide Distribution - US (nationwide) and the country of S. Korea
Product codes and lots: Lot number: 11NP685 . Exp 2014- 11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1856-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1855-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-21
Z-1856-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-21

Product code MCN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)