The Recall Desk
CriticalFDA (Devices)·Z-2304-2014·Announced 2014-09-10

Customed Laparoscopy Convenience Packs Recalled for Packaging Integrity Concerns

Customed, Inc. is recalling 30 lots of EO sterilized laparoscopy convenience packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly identifies the agency classification as Class I. Per the severity rubric, an FDA Class I recall mandates a score of 5 (Critical), as it represents a reasonable probability that use of the product will cause serious adverse health consequences or death.

Plain-English summary

Customed, Inc. is recalling 30 lots of Customed Laparoscopy convenience packs. These products are EO sterilized surgical packs containing multiple components, including gowns, table covers, suture, sponges, syringes, needles, and drapes, packaged in polyester/polyethylene breather bags with Tyvek double vents. The recall involves 6,977 units distributed worldwide, including the United States (nationwide, specifically Florida, Puerto Rico, and USVI) and several international locations such as Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.

The recall was initiated because Customed determined that there is a possibility that packaging integrity may be compromised on different catalog numbers. This defect could result in an injury to the patient due to product contamination or the loss of the product's sterility condition. The agency has classified this recall as Class I.

Healthcare facilities and distributors should stop using the affected lots immediately. The specific lot numbers involved are: 111071871, 112041386, 112041433, 112051660, 112051712, 112062301, 112062560, 112093834, 112124408, 112124903, 112125312, 113015686, 113026162, 113036772, 113047331, 113057830, 113068022, 113068136, 113078564, 113089015, 113089177, 113099559, 131110062, 131110395, 131110575, 140111089, 140111447, 140211739, 140312327, and 140513052.

The recalled product

Product
Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. EO steriliz
Manufacturer
Customed, Inc
Category
Medical Device — Surgical Supplies
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 900-028

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

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Same hazard · loss of sterility

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