Recall Z-1452-2015 ยท KGN Wound Dressing With Animal-Derived Material(S)
Integra LifeSciences Corp.
Integra Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty plastic syringe with Luer-Lok" tip - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material - A syr
| Date | Apr 16, 2015 (initiated Mar 13, 2015) |
| Status | Terminated |
| Reason | A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for the attributes of visual appearance during dispensing and force vs. displacement (force needed for product to be extruded from the syringe). |
| Root cause | Unknown/Undetermined by firm |
| Action | Integra Life Sciences Inc. sent a Recall letter/Recall acknowledgement and return form dated March 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Integra asks customers to review inventory and determine if any of the affected inventory is in possession. The attached Recall Acknowledgement and Return Form should be completed and returned. Customer service will contact the customer upon receipt of the form and provide an RMA number. Questions can be directed to Customer Service at 1-888-301-0203. |
| Quantity | 287 packages ( 179 US 108 OUS ) |
| Distribution | Worldwide Distribution - US Distribution and to the countries of and to the countries of Greece, France, Italy, Spain, Switzerland, South America, Turkey and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.