The Recall Desk
HighFDA (Devices)·Z-2342-2014·Announced 2014-09-10

Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

Customed, Inc. is recalling 5,574 units of EO sterilized surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that the use of the product will cause serious adverse health consequences or death. The hazard involves potential loss of sterility and contamination of surgical instruments, which poses a significant risk of infection or injury to patients, even though specific injuries are not yet reported in the text.

Plain-English summary

Customed, Inc. is recalling 5,574 units of EO sterilized surgical convenient packs, specifically the 0.B. Pack (Product Code 900-645). The affected products are packaged into polyester/polyethylene breather bags with Tyvek double vents. The recall covers 51 specific lots distributed worldwide, including the United States (nationwide, Florida, Puerto Rico, and USVI) and several international locations such as Tortola, Trinidad, the 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 loss of the sterility condition of the surgical instruments and supplies contained within the packs.

Healthcare facilities and distributors should stop using the affected lots immediately. Consumers and medical professionals should check their inventory against the 51 lot numbers listed in the recall notice. If the product is found, it should be quarantined and returned to Customed, Inc. or the distributor for credit or replacement, in accordance with the firm's recall instructions.

The recalled product

Product
0.B. PACK - - (1) TABLE COVER 44" x 90" (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (3) TOWELS ABSORBENT 15" x 20" (1) PAD OBSTETRICAL X-LARGE (1) VAGINAL SPONGE XRD (10) GAUZE SPONGES 4" X 4" 12PLY XRD (
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 900-645

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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