Agency classClass IOur severity:Critical FDA (Devices)·Z-2486-2014·Announced 2014-09-10

Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

Customed, Inc. is recalling specific lots of EO-sterilized surgical 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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Customed, Inc. has initiated a recall for specific lots of EO-sterilized surgical convenient packs, including items such as gowns, towels, and drapes. The recall involves two lots, totaling 354 units, with catalog code 900-2515. The affected products were distributed worldwide, including in the United States (nationwide, Florida, Puerto Rico, USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.

The recall was issued because Customed determined that there is a possibility that packaging integrity may be compromised on these products. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The agency has classified this recall as Class I.

Healthcare facilities and consumers who have these specific lots should stop using the products immediately. Users should check their inventory for the affected lot numbers (112104283 and 113078531) and contact Customed, Inc. for instructions on how to return or dispose of the recalled items.

The recalled product

Product: Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (2) STRIPS TAPE 24" X 4" (1) SUTURE BAG FLORAL (1) SHEET SPLIT W/ADHESIVE 1 08" X…
Manufacturer: Customed, Inc
Category: Medical Device — Surgical Packs
Hazard: loss-of-sterility
product-contamination

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)

900-2515
2 lots: 112104283 113078531

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 →

Same manufacturer · Customed, Inc

See all →

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Same hazard · loss of sterility