The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2465-2014·Announced 2014-09-10

Customed Recalls Cystoscopy Packs Due to Potential Packaging Integrity Issues

Customed, Inc. is recalling Cystoscopy 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. has initiated a recall of Cystoscopy Packs, which are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The recall involves two specific lots, identified by product code 900-2482 and lot numbers 112072726 and 113078522, totaling 600 units. The affected products contain various surgical items, including table covers, towels, leggings, drapes, and gowns.

The recall was issued because Customed determined that there is a possibility that the packaging integrity may be compromised on these specific catalog numbers. If the packaging is compromised, it could result in an injury to the patient due to product contamination or the loss of the product's sterile 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. Users of these medical devices should check their inventory for the specific lot numbers listed and contact Customed, Inc. for further instructions on how to handle the recalled items.

The recalled product

Product
CYSTOSCOPY PACK Ill (1) (2) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W/7" CUFF 30" X 42" (1) DRAPE CYSTOSCOPY T 60" X 87" 35" SMS STD (1) GOWN SURG.REINFORCED XL EXTRA LONG LEVEL IV Product Usage: EO…
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 900-2482
  • 2 lots 112072726 113078522

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 →

Related recalls

Same manufacturer · Customed, Inc

See all →

Same hazard · contamination

See all →

Similar recalls