The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2455-2014·Announced 2014-09-10

Customed Recalls Surgical Ear Packs Due to Packaging Integrity Concerns

Customed, Inc. is recalling 27 units of surgical ear packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.

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 27 units of surgical ear packs, product code 900-2423, across three lots (131010019, 140111210, 140312131). The recall was initiated because the company determined there is a possibility that the packaging integrity of these medical device packs may be compromised.

The affected products are EO sterilized surgical convenient packs packaged in polyester/polyethylene breather bags with Tyvek double vents. The recall covers distribution in the United States (including Florida, Puerto Rico, and the US Virgin Islands) as well as international locations including Tortola, Trinidad, the Dominican Republic, Costa Rica, and Mexico.

The potential compromise in packaging integrity could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. Users of these medical devices should stop using the affected lots and contact the manufacturer for further instructions.

The recalled product

Product
EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) NEEDLE HYPODERMIC 1 80 X I Y, ( I) WASI-l BASIN ROUND 6QT (I) INSTRUMENT POUCH 7 X I I 2 COMPART (I) STRIP STER I CLOSURE W' X…
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 900-2423
  • 3 lots 131010019 140111210 140312131

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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