Customed Recalls EO Sterilized ENT Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 39 lots of EO sterilized ENT surgical 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 involves a risk-of-harm product (loss of sterility/contamination) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Customed, Inc. is recalling 39 lots of EO sterilized ENT surgical packs, totaling 1,771 units. The affected products are packaged into polyester/polyethylene breather bags with Tyvek double vents. The recall involves multiple catalog numbers and specific lot numbers ranging from 110102428 to 140613609.
The recall was initiated because Customed determined there is a possibility that packaging integrity may be compromised on these lots. This defect could result in an injury to the patient due to product contamination or loss of sterility condition. The source text does not report any specific illnesses or injuries associated with this recall.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting Florida, Puerto Rico, and USVI) 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 instructions on return or replacement.
The recalled product
- Product
- E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED L/F (1) TUBE SUCTION CONNECT %" X 12' L/F (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CAUTERY PENCIL H
- 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 900-1482
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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