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
Check against the official notice below — it lists the full affected range.
Integra LifeSciences Corp. is recalling Integra Flowable Wound Matrix Size 3cc (Model Number FWD301 for US and FDR301 for non-US) because a lot distributed in late 2013 and early 2014 did not meet stability acceptance criteria. Specifically, the product failed to meet standards for visual appearance during dispensing and the force required to extrude the product from the syringe. The recall affects 287 packages (179 in the US and 108 outside the US) distributed worldwide to Greece, France, Italy, Spain, Switzerland, South America, Turkey, and the United Kingdom. The affected lot numbers are 305000293250, 305000293251, and 305000298616, with corresponding syringe lot numbers 10500028786, 105000288118, and 105N00288965.
The source does not specify a remedy or what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
Reason for recall: 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). 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. Quantity: 287 packages ( 179 US 108 OUS ) Lot/code info: 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.