Agency classClass IOur severity:Critical FDA (Devices)·Z-2456-2014·Announced 2014-09-10

Customed Recalls Extremity Arm Packs Due to Packaging Integrity Concerns

Customed, Inc. is recalling 112 units of Extremity Arm 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 metadata explicitly identifies the agency classification as Class I. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) regardless of other factors.

Plain-English summary

Customed, Inc. is recalling 112 units of Extremity Arm Packs, a medical device containing various surgical supplies such as stockinettes, wraps, bandages, gauze, and surgical instruments. The recall involves four specific lots with product code 900-2438 and lot numbers 140211465, 140211702, 140412558, and 140512912.

The recall was initiated because Customed determined there is a possibility that the packaging integrity of these units 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.

The affected products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.

The recalled product

Product: EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT WRAP 6" X 5yds (3) BANDAGE ELASTIC 4" X 5yds (1) BANDAGE ESMARK 6" X 9 (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECTX 12' (1)…
Manufacturer: Customed, Inc
Category: Medical Device — Surgical Packs
Hazard: contamination
loss-of-sterility

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 900-2438
4 lots 140211465 140211702 140412558 140512912

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

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Same hazard · contamination