The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2383-2014·Announced 2014-09-10

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.

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 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…
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 (2)

  • Product code 900-1295
  • 2 lots: 111030561 112031009

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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