The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2526-2014·Announced 2014-09-10

Customed Recalls Face Pack FJG Due to Potential Packaging Integrity Issues

Customed, Inc. is recalling Face Pack FJG surgical kits 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 one lot of Face Pack FJG surgical kits, code 900-3116. The recall involves 16 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 specific lot number is 131210805.

The recall was initiated because Customed determined there is a possibility that the packaging integrity of the kits may be compromised. This defect could result in product contamination or a loss of the sterile condition, which poses a risk of injury to patients using the equipment. The affected kits contain various surgical supplies, including gowns, towels, needles, blades, and gloves, and are EO sterilized.

Healthcare facilities and consumers who have purchased or received these specific Face Pack FJG kits should stop using them immediately. Users should contact Customed, Inc. for further instructions on how to return or dispose of the affected products.

The recalled product

Product
Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1) SHEET ENT SPLIT 11 0" X 77" SMS (1) COVER TABLE REINFORCED 44" X 78" (20) GAUZE SPONGE 4"…
Manufacturer
Customed, Inc
Category
Medical Device — Surgical Kits
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)

  • 900-3116
  • 1 lot: 131210805

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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