FDA Device recall Z-1452-2015
Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable W…
- FDA Device
- Class II
- terminated
- Published 2015-04-22
On 2015-04-22 the FDA classified a Class II recall of Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable W… by Integra Lifesciences, citing 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 vis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1452-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-13 |
| Published | 2015-04-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | n/a |
Product
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 syringe-to-syringe Luer-Lok" adapter / connector - A flexible plastic tube (injector) with Luer-Lok" connector Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.
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).
Identifiers
| code_info | Model Number FWD301 (US) & FDR301 (Non-US) The following Lot Numbers on the packaged kits are affected: - 305000…Model Number FWD301 (US) & FDR301 (Non-US) The following Lot Numbers on the packaged kits are affected: - 305000293250, 305000293251, 305000298616 (foreign) The syringes within the packaged kits are also Lot numbered. For the packaged kit Lot Numbers above, the corresponding respective syringe Lot Numbers are: - 10500028786, 105000288118, 105N00288965 (foreign) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1452-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.