The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2411-2014·Announced 2014-09-10

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.

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 classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product 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)…
Manufacturer
Customed, Inc
Category
Medical Device — Surgical Packs
Hazard

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

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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 →

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