Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 32 lots of Laparotomy 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 in the rubric.
Plain-English summary
Customed, Inc. is recalling 32 lots of Customed Laparotomy Packs, which are convenience packs containing multiple surgical components such as drapes, gowns, towels, sponges, and surgical solutions. The recall involves 8,954 units distributed worldwide, including the United States (nationwide, specifically Florida, Puerto Rico, and USVI) and several international locations such as Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
The recall was initiated because Customed determined that there is a possibility that the packaging integrity of the products may be compromised. This defect could result in product contamination or a loss of the sterile condition, which poses a risk of injury to patients using the equipment during surgical procedures.
The affected product code is 900-149. The specific lot numbers involved in this recall are: 111113165, 111123349, 112010052, 112010280, 112030621, 112041077, 112051768, 112062421, 112083062, 112093900, 112104147, 112114637, 112114952, 113015429, 113025941, 113026204, 113036749, 113047333, 113057861, 113078258, 113078600, 113089192, 113109733, 131110083, 131110399, 131110578, 131210961, 140111409, 140211872, 140312328, 140412830, and 140513345. Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the affected products.
The recalled product
- Product
- Customed Laparotomy Pack , convenience pack include multiple components: drape laparot., gown, absorbent towel, scrub, stck sponges/ gauzes, table cover, drape sheet, suture bag, duraprep surgical solution, cloth huck towels, utility bowls, suction tube, scalpel, Mayo Tray, Mayo
- 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 900-149
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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