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.
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 involves a risk-of-harm product (loss of sterility/contamination) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed illness.
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
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
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.
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