The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2380-2014·Announced 2014-09-10

Customed Recalls OB Packs Due to Potential Packaging Integrity Compromise

Customed, Inc. is recalling OB 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 OB Packs (Product Code 900-1238, Lot 109071538) due to a potential compromise in packaging integrity. The recall involves 30 units from a single lot. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.

The recall was initiated because the compromised packaging could result in product contamination or a loss of sterility condition. This poses a risk of injury to patients using the medical supplies. The source text notes that the issue may affect different catalog numbers and multiple lots, though the specific quantity listed is 30 units for the identified lot.

The affected products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Consumers and healthcare facilities should stop using the affected OB Packs and contact Customed, Inc. for further instructions or a replacement.

The recalled product

Product
OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/TAPE (1) PLASTIC BOWL W/Lid 70 oz. (1) EAR/ULCER SYRINGE 2oz. L/Free (1) UMBILICAL CORD CLAMP (1) BABY BEANNIES (1) PVP SCRUB 8" STICK…
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 900-1238
  • 1 lots: 109071538

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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