Customed Recalls General Cosmetic Pack Due to Packaging Integrity Concerns
Customed, Inc. is recalling General Cosmetic Pack FCSC (Code 900-3113) 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 (loss of sterility/contamination) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Customed, Inc. is recalling the General Cosmetic Pack FCSC, Code 900-3113, due to a potential compromise in packaging integrity. The recall involves two specific lots (131110435 and 131210803) totaling 18 units. The product consists of 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 the sterile condition, which poses a risk of injury to patients using the items.
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 stop using these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- General Cosmetic Pack FCSC, Code 900-3113, contains: (1) COVER MAYO STAND REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (2) GOWN LARGE STANDARD SMS AAMIIII (1) TABLE COVER REINFORCED 50" X 90" LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOU
- 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)
- 900-3113
- 2 lots: 131110435 131210803
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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