Customed Recalls Cervical Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling cervical 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, aligning with the High severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Customed, Inc. is recalling specific lots of Cervical Packs intended for use in advanced ambulatory surgical centers. The recall involves 160 units across two lots, identified by product code 900-2286 and lot numbers 112082968 and 113057620. The affected products are EO sterilized surgical convenient packs packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because Customed determined there is a possibility that the packaging integrity of these items may be compromised. This defect could result in product contamination or a loss of the sterile 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) as well as in Tortola, Trinidad, the Dominican Republic, Costa Rica, and Mexico. Users of these surgical packs should stop using the affected lots and contact the recalling firm for further instructions.
The recalled product
- Product
- CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60" X 77" DRAPE REINFORCED (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) SKIN MARKER W/RULER (1
- 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 900-2286
- 2 lots 112082968 113057620
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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