Customed Recalls Laparoscopy Cholecystectomy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 26 lots of Laparoscopy Cholecystectomy 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, which aligns with the 'High' severity criteria for theoretical hazards in medical devices.
Plain-English summary
Customed, Inc. is recalling 26 lots of Laparoscopy Cholecystectomy Packs (Product code 900-576). The recall involves 1,412 units distributed worldwide, including the United States (nationwide, Florida, Puerto Rico, USVI), Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
The recall was initiated because Customed determined that the packaging integrity of the products may be compromised. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
Healthcare facilities and distributors should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be quarantined and returned to Customed, Inc. according to the instructions provided by the manufacturer.
The recalled product
- Product
- LAPAROSCOPY CHOLECYSTECTOMY PACK - (1) SHEET LAPAROS/ABDOMINAL UF (1) MAYO STAND COVER REINFORCED UF (1) BLADE SURGICAL #11 STAINLESS STEEL (1) DRAPE SHEET 41 " X 58" SMS UF (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) TUBE SUCTION CONNEC. 3/16" x 12' UF (3) TOWEL ABSO
- 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 900-576
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.
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