Customed Recalls Laparoscopy Chole Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 843 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 (sterile surgical supplies) 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 16 lots of Laparoscopy Chole Packs, totaling 843 units. The recall involves specific surgical supplies including drapes, suction tubes, surgical blades, and other instruments packaged in polyester/polyethylene breather bags with Tyvek double vents.
The company determined that there is a possibility that packaging integrity may be compromised on different catalog numbers. This defect could result in an injury to the patient due to product contamination or the loss of the product's sterility 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. The specific product code is 900-1688. The 16 affected lot numbers are: 112114380, 112114643, 113036740, 113047004, 113057426, 113068154, 113088751, 113099276, 131110193, 140211464, 140211704, 140311926, 140312434, 140412555, 140513103, and 140513462.
The recalled product
- Product
- LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2) SHEET DRAPE 42" X 57" SMS (1) TUBE SUCTION CONNECT. %" X12' LIF (1) SURGICAL BLADE #10 STAINLESS STEEL (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LAPAROSC. ABD 102" X 122" X 78" WITH POUC
- 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 900-1688
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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