Customed Recalls VEIN PACK Surgical Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling specific lots of VEIN PACK surgical kits because packaging integrity may be compromised, potentially leading to 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 classification is Class I, which mandates a minimum severity score of 4 according to the rubric, despite the hazard being a potential loss of sterility rather than a reported injury.
Plain-English summary
Customed, Inc. has initiated a recall of VEIN PACK surgical convenient packs. The affected products are EO sterilized and packaged in polyester/polyethylene breather bags with Tyvek double vents. The recall involves three specific lots (109050994, 110020540, 110081960) totaling 48 units. These products were distributed nationwide in the United States, including Puerto Rico and the US Virgin Islands, as well as in Tortola, Trinidad, the Dominican Republic, Costa Rica, and Mexico.
The recall was issued because Customed determined there is a possibility that the packaging integrity may be compromised. This defect could result in product contamination or a loss of the sterile condition, which poses a risk of injury to patients. The agency has classified this recall as Class I.
Healthcare facilities and distributors should stop using the affected lots immediately. Users should check their inventory for the specific lot numbers listed above and contact Customed, Inc. for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF (1) EXTREMITY SHEET ABS LIF (1) WRAPPER 36" X 36" (1) IMP. STOCKINETTE 14" X 48" LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek…
- 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)
- Product code 900-1401
- 3 lots: 109050994 110020540 110081960
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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