Customed Recalls Central Line Drape Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Central Line Drape Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (loss of sterility/contamination) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed illness.
Plain-English summary
Customed, Inc. is recalling Central Line Drape Packs, which include procedural masks, drape sheets, nurse caps, brachial angio drapes, wrappers, gowns, and towels. The recall involves 6 lots totaling 420 units. The product is EO sterilized and packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because Customed determined that packaging integrity may be compromised on different catalog numbers. This defect could result in an injury to the patient due to product contamination or the loss of the product's sterility condition.
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. The specific product code is 900-2455, and the affected lot numbers are 111123428, 112010145, 112020523, 112030832, 112041305, and 112051957.
The recalled product
- Product
- CENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free (1) DRAPE SHEET 41" X 58" SMS L/Free (1) CAP NURSE 21" GREEN BOUFFANT (1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED CIRC/ FENE (1) WRAPPER 24" X 24" GOWN LGE STANDARD SMS VELCRO NECK TOWELS
- 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 900-2455
- 6 lots 111123428 112010145 112020523 112030832 112041305 112051957
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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