Customed Recalls Umbilical Vessel Catheter Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling specific lots of Umbilical Vessel Catheter Kits 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 identifies the recall as 'Class I' by the agency. According to the severity rubric, if the agency's own classification is FDA Class I, the score must never go below 4, resulting in a 'Severe' label.
Plain-English summary
Customed, Inc. has initiated a recall of Umbilical Vessel Catheter Kits, product code 900-1408. The recall affects 7 specific lots with a total of 176 units. The affected lots are identified by the following numbers: 113015546, 113057835, 140211780, 140412600, 140513084, 113047152, and 112051753.
The recall was issued because Customed determined there is a possibility that the packaging integrity of these kits may be compromised. This defect could result in product contamination or a loss of sterility, which poses a risk of injury to patients. The agency classifies this as a Class I recall.
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. Users should check their inventory for the specific lot numbers listed and contact Customed, Inc. for instructions on returning the affected units.
The recalled product
- Product
- UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1) FENESTRATED DRAPE 18" x 26" LIF (1) NEEDLE HOLDER BAUMGARTNER 5" (2) HALSTED MOSQUITO CVD 5" SERRAT (1) ADSON FORCEP TISS. Wff (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (6) GAUZE SPONGE 2"…
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Kits
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 900-1408
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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