Customed Recalls D & C Laparoscopy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling D & C Laparoscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (loss of sterility/contamination) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Customed, Inc. is recalling D & C Laparoscopy Packs (Product code 900-1496) due to a determination that packaging integrity may be compromised across multiple catalog numbers and lots. The recall involves 22 lots totaling 968 units. The specific lots affected are: 112041078, 112051677, 112062422, 112114953, 113015550, 113025817, 113026047, 113036320, 113036750, 113057690, 113067952, 113088734, 113099274, 113109735, 131110178, 131210749, 140111077, 140211644, 140311921, 140412602, 140513092, and 140513391.
The recall is being conducted because the compromised packaging integrity could result in product contamination or a loss of sterility condition. This poses a potential risk of injury to patients who use the products. The products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The affected products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the products if found. They should contact Customed, Inc. for further instructions on return or disposal.
The recalled product
- Product
- D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) DRAPE UTILITY UF (1) TRAY MAYO SMALL LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SUTURE BAG FLORAL LIF (1) TUBE SUCTION CONNECT X" X 12' LIF (1) SYRINGE
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product code 900-1496
Distribution
Part of a larger recall action
This product is one of 233 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 233 products in this recall →Related recalls
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