Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 612 units of Urology Pack 900-2510 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 agency classified this as a Class I recall, and the rubric mandates a score of at least 4 for any FDA Class I recall.
Plain-English summary
Customed, Inc. is recalling 612 units of the Urology Pack, product code 900-2510. The recall involves 10 specific lots of these EO sterilized surgical convenient packs, which are packaged in polyester/polyethylene breather bags with Tyvek double vents. The affected lots are identified by the following codes: 113046981, 113057471, 113078312, 113088798, 113099429, 131110251, 131210649, 140111211, 140312133, and 140412657.
The recall was initiated because Customed determined there is a possibility that the packaging integrity may be compromised on these units. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The agency has classified this as a Class I recall.
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. Healthcare facilities and consumers should stop using these products and contact Customed, Inc. for instructions on return or replacement.
The recalled product
- Product
- Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO 11 0" X 63" W/LEGG/POUCH FEN UF (10)GAUZE SPONGE 4" X 4" 12PL Y (1) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) TUR Y SET 81 " 2.1M REGULAR CLAM (1) GOWN SURG REINFORCED LGE TOWEL &…
- 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 900-2510
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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