Customed Recalls Laparoscopy Chole Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 681 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 pack) 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 11 lots of Laparoscopy Chole Packs, totaling 681 units, due to a potential compromise in packaging integrity. The recalled products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The recall is being issued because the compromised packaging could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The affected lots are identified by the following codes: 112030703, 112061278, 112114387, 112114491, 112114877, 113068160, 113078570, 113089022, 113099283, 131110222, and 140613472.
The 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 immediately.
The recalled product
- Product
- LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm
- 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 900-2004
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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