Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 3,066 units of EO sterilized surgical convenient 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, and the hazard is theoretical (possibility of compromised integrity), which aligns with the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Customed, Inc. is recalling 3,066 units of EO sterilized surgical convenient packs, specifically the 'CARPALTUNNELLARGE' catalog number, across 38 lots. The recall is due to a determination that packaging integrity may be compromised on different catalog numbers. The affected products are packaged into polyester/polyethylene breather bags with Tyvek double vents.
The compromised packaging integrity could result in product contamination or loss of sterility condition, which poses a risk of injury to the patient. The recall covers 38 specific lots, including lot numbers 110092282 through 140311948.
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. Consumers and healthcare facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using the affected products if found.
The recalled product
- Product
- CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF (2) DRAPE SHEET 41 " X 58" SMS (1) BANDAGE GAUZE 4" STRETCH (1) NEEDLE HYPODERMIC 25G X 5/8" (1) STOCKINETTE 6" X 48" LIF (2) CLOTH HUCK T
- 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 900-742
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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