Genzyme Recalls Seprafilm Adhesion Barrier Due to Packaging Sterility Risk
Genzyme Corporation is recalling 1,285 units of Seprafilm Single Site Adhesion Barrier because a packaging defect may compromise product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility may be compromised, posing a risk of harm (infection) even though no specific injuries are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Genzyme Corporation is recalling 1,285 units of Seprafilm Single Site Adhesion Barrier (Re-order Number: 6641-01). The recall is due to a packaging defect that may compromise the sterility of the product.
The affected product is indicated for use in patients undergoing abdominal or pelvic laparotomy to reduce postoperative adhesions. The recall covers Lot 11NP685, which has an expiration date of November 2014. The product was distributed nationwide in the United States and in South Korea.
Consumers and healthcare providers should stop using the affected product and contact Genzyme Corporation for further instructions or a replacement.
The recalled product
- 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 adhesion
- Manufacturer
- Genzyme Corporation
- Affected units
- 1,285
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: 11NP685 . Exp 2014- 11
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Genzyme Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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