Customed Recalls Surgical Ear Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 123 units of surgical ear packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
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 is classified as FDA Class I, which indicates a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The hazard involves potential loss of sterility and contamination, which are high-risk factors for surgical instruments.
Plain-English summary
Customed, Inc. is recalling 123 units of surgical ear packs, product code 900-2234, across eight lots. The recall is due to a determination that packaging integrity may be compromised on different catalog numbers. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The compromised packaging integrity could result in an injury to the patient due to product contamination or loss of sterility condition. The recall covers 8 lots with the following lot numbers: 112030726, 113088792, 113109792, 131110112, 131110338, 140211660, 140412835, and 140512993.
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. Consumers and healthcare facilities should stop using these products and contact Customed, Inc. for further instructions.
The recalled product
- Product
- EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN lO in 700cc ( I ) GOWN XL SMS IM P. REINFORCED ( I ) NEEDLE HYPODERM IC 1 8G X I 'h ( I ) WASH BASIN ROUND 6QT ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT (I) STERI STR I P
- 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 (1)
- Product code 900-2234
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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