Customed Recalls Universal Pack II Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Universal Pack II 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 packs) 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 Universal Pack II surgical packs (catalog number 900-2509) due to a potential defect in packaging integrity. The recall involves three specific lots (112020357, 112051971, and 113078530) totaling 612 units. These products are EO sterilized surgical convenient packs packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because the company determined that the packaging integrity may be compromised on these lots. This defect could result in product contamination or a loss of sterility, which poses a risk of injury to patients. The affected products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
Healthcare facilities and consumers should stop using these specific lots immediately. Users should check their inventory for the catalog number 900-2509 and the lot numbers listed above. If found, the products should be quarantined and returned to Customed, Inc. for further instructions.
The recalled product
- Product
- Universal Pack II (2) Customed 900-2509 (1) MAYO STAND COVER REINFORCED (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTTOM ABSORBENT REINFORCED 71" X 62" STD SMS WITH TAPE (1) DRAPE TOP W/ADHESIVE 1 08" X 50" STD SMS (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 50" X 9
- 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)
- 900-2509
- 3 lots: 112020357 112051971 113078530
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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