Customed Recalls Premium Urology Packs Due to Potential Sterility Loss
Customed, Inc. is recalling Premium 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 (injury due to contamination or loss of sterility) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Customed, Inc. is recalling the Premium Urology Pack, a sterile surgical convenient pack containing items such as a lithotomy drape, absorbent towels, and a urinary drainage bag. The recall involves two specific lots (111030561 and 112031009) totaling 258 units. The company determined that there is a possibility that the packaging integrity may be compromised on these units.
The recall is being conducted because compromised packaging could result in product contamination or a loss of the sterility condition. This poses a risk of injury to patients who use the products. The affected products were distributed worldwide, including in the United States (nationwide, specifically Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
Healthcare facilities and consumers should stop using the affected Premium Urology Packs immediately. Users should check their inventory for the specific lot numbers 111030561 and 112031009. If these lots are found, they should be removed from service and returned to the supplier or the manufacturer for credit or replacement.
The recalled product
- Product
- PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) ABSORBENT TOWELS UF (1) MAYO STAND COVER REINFORCED UF (1) URINARY DRAINAGE BAG 2000ml ANTI-REFLUX UF (1) GOWN SURG. REINFORCED LARGE T/WRAP (1) UTILITY BOWL 32 OZ. (1) TUBE SUCTION CONNEC. W' X 12
- 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 900-1295
- 2 lots: 111030561 112031009
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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