Recall Z-1897-2012 ยท LMF Agent, Absorbable Hemostatic, Collagen Based
Ethicon, Inc.
Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arter
| Date | Jun 27, 2012 (initiated Apr 3, 2012) |
| Status | Terminated |
| Reason | The lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the potential to be non-sterile due to an undetected air leak which occurred during the manufacturing process. |
| Root cause | Packaging process control |
| Action | Ethicon Inc. sent a Urgent Voluntary Product Recall letter dated April 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you have any product subject to this voluntary recall, please remove it from your inventory immediately and return it per the following instructions. Return product to Stericycle using the enclosed pre-paid shipping label. Shipping fees wil be charged directly to Ethicon through the use of this shipping label. No reimbursements will be made for the shipping charge if this label is not |
| Quantity | 27,396 kits |
| Distribution | USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.