Reported Apr 22, 2015 · Terminated
Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- 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
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published FWD301(US) & FDR301 (Non-US) The following — 305000293250305000293251305000298616Lot 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 — 105000288118Lot Numbers are: - 10500028786, 105000288118, 105N00288965 (foreign) - Amount recalled
- 287 packages ( 179 US 108 OUS )
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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