Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 214 units of 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 (sterile surgical packs) where injury has not yet been reported, fitting the High severity criteria for potential contamination or loss of sterility.
Plain-English summary
Customed, Inc. is recalling 214 units of laparoscopy packs, product code 900-2204, across five specific lots. The recall is due to a determination that packaging integrity may be compromised on different catalog numbers. The affected lots are 112050723, 112062283, 112083422, 112093930, and 112125070.
The compromised packaging could result in an injury to the patient due to product contamination or loss of sterility condition. The product consists of 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. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled items.
The recalled product
- Product
- LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) MAYO STAND COYER REINFORCED LIF ( I ) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4) TOWEL ABSORBENT I 5" X 20" LI
- 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 (2)
- Product code 900-2204
- 5 lots 112050723 112062283 112083422 112093930 112125070
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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