Customed Recalls Neuro Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling TRAATEK NEURO PACK surgical kits 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 (injury due to contamination or loss of sterility) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Customed, Inc. is recalling the TRAATEK NEURO PACK, a sterile surgical convenient pack containing various medical supplies such as towels, gloves, syringes, and drapes. The recall involves one lot (131110141) with 50 units. The product is EO sterilized and packaged in a polyester/polyethylene breather bag with Tyvek double vents.
The recall was initiated because Customed determined that there is a possibility that packaging integrity may be compromised on different catalog numbers. This defect could result in product contamination or a loss of sterility 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. Users should stop using the recalled products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) CAUTERY TIP POLISHER LIF (8) TOWEL CLOTH HUCK (BLUE) ( 1) BULB SYRINGE 60cc LIF ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE (2) LITE GLOVE ( 1) TUBE SUCTION CONNECT. Y.."
- 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 900-1983
- 1 lots: 131110141
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.
See all 233 products in this recall →Related recalls
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