Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 440 units of Urology Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must never go below 4. The potential for loss of sterility and patient injury supports a Severe rating.
Plain-English summary
Customed, Inc. is recalling 20 lots of Urology Packs, totaling 440 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 specific product code is 900-1738.
The recall was initiated because the company determined that the packaging integrity may be compromised on different catalog numbers. This defect could result in an injury to the patient due to product contamination or loss of sterility condition. The agency has classified this recall as Class I.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting 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 further instructions.
The recalled product
- Product
- UROLOGY PACK - (4) ABSORBENT TOWELS UF (2) GOWN SURGICAL POLY-REINF. BREATHABLE XL LEVEL IV (1) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F (1) TUR Y SET, 81 "2 .1M REGULAR CLAM (1) TABLE COVER 44" x 90" (1) DRAPE LITHO 11 0" X 63" WITH POUCH /LEGGING FEN (1) TUBE SUCTION…
- 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 900-1738
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.
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