Customed Recalls Laparoscopic Colorectal Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling specific lots of laparoscopic colorectal surgical 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 three lots of Laparoscopy Colorectal Surgical Packs. The recall involves 280 units across multiple catalog numbers. The affected product codes are 900-2259A, with lot numbers 140312025, 140412651, and 140612902.
The recall was initiated because Customed determined that the packaging integrity of these surgical packs 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 during surgical procedures.
The affected products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and the U.S. Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Healthcare facilities and distributors should stop using the affected lots and contact Customed, Inc. for instructions on returning or disposing of the products.
The recalled product
- Product
- LAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STAIN
- 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 900-2259A
- 3 lots 140312025 140412651 140612902
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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