Customed Recalls EO Sterilized Laparotomy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 550 units of EO sterilized laparotomy basic packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.
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. According to the severity rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Customed, Inc. has initiated a recall of 550 units of EO sterilized laparotomy basic packs (Product Code 900-547) across 19 lots. The recall is due to a determination that packaging integrity may be compromised on different catalog numbers. The affected products are surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The compromised packaging integrity could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The recall covers 19 specific lots, including lot numbers 109010180, 109030602, 110020394, 110041044, 110061584, 110071846, 110112813, 111030690, 111102881, 112020520, 112030884, 112051719, 112083433, 113025793, 113036491, 113046966, 113057746, 140111076, and 140312175.
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. No specific instructions for consumers are provided in the source text, but the recall is classified as Class I by the FDA.
The recalled product
- Product
- LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1) COVER MAYO STAND REINFORCED UF (2) TOWEL ABSORBENT 15" X 20" UF (1 0) GAUZE SPONGES XRD 4" X 4"-12PL Y (2) DRAPE SHEET 41 " X 58" SMS UF (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical…
- 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 900-547
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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