Customed Recalls Laparoscopy ABO Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling specific lots of Laparoscopy ABO 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 criteria for a High severity score.
Plain-English summary
Customed, Inc. is recalling five lots of Laparoscopy ABO Packs, totaling 1,269 units. The recall involves product code 900-2483 and specific lot numbers: 112020352, 112051963, 112072727, 113078523, and 140513401. These products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because Customed determined there is a possibility that packaging integrity may be compromised on these catalog numbers. This defect could result in an injury to the patient due to product contamination or the loss of the product's sterile condition.
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 affected products if found.
The recalled product
- Product
- LAPAROSCOPY ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL I WRAP (2) TOWELS ABSORBENT 15" X 20" (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITH TAPE (1) SUTURE BAG FLORAL (1) DRAP
- 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 900-2483
- 5 lots 112020352 112051963 112072727 113078523 140513401
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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