Customed Recalls Laparoscopy Chole Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 1,671 units of Laparoscopy Chole 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 High severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Customed, Inc. is recalling 1,671 units of Laparoscopy Chole Packs (Product Code 900-1059) across 16 lots. The recall is due to a determination that packaging integrity may be compromised on different catalog numbers. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The compromised packaging integrity could result in an injury to the patient due to product contamination or loss of sterility condition. The recall covers 16 specific lots, including lot numbers 112030823, 113047111, 113057410, 113057823, 113078454, 113078566, 113099561, 113109983, 131110149, 131110397, 131110577, 131210955, 140211914, 140312430, 140513062, and 140513474.
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 stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWELS 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SURGICAL DURAPREP SOLUTION 26ml LIF (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. (1) DRAPE LASER CAMERA W/EL 6" X 96" (1) LAPAROSCOP
- 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 900-1059
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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