Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 14 lots of Urology 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 (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential contamination or loss of sterility.
Plain-English summary
Customed, Inc. is recalling 14 lots of Urology Packs, product code 900-1742, due to a potential compromise in packaging integrity. The recalled items are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The recall involves 325 units distributed across the United States (including Puerto Rico and USVI) and internationally in Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
The company determined that the possibility of compromised packaging integrity could result in an injury to the patient due to product contamination or loss of sterility condition. The affected lots are identified by the following lot numbers: 111113032, 111123382, 112010089, 112020407, 112041202, 112051876, 112083407, 112093915, 112125157, 113015435, 113036757, 140412562, 140513111, and 140513393.
Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the affected products. The source text does not specify a particular consumer action beyond the implication that the products should not be used if the packaging integrity is in question.
The recalled product
- Product
- UROLOGY PACK - (3) TOWELS ABSORBENT 15" X 20" UF (1) WASH BASIN ROUND 6QT. (1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN (1) BAG URINARY DRAINGAGE 2000ml ANTI-REFLUX (1) BAG SUTURE FLORAL (1) GOWN SURG. REINFORCED X-LARGE T/VIJRAP (1) TABLE COVER 44" X 90" UF (2) DRAP
- 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 900-1742
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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