Customed Recalls Laminectomy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Laminectomy 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 for theoretical hazards in medical devices.
Plain-English summary
Customed, Inc. is recalling Laminectomy Packs (Product Code 900-1202) due to a determination that packaging integrity may be compromised across multiple catalog numbers and lots. The recall involves 12 specific lots and approximately 450 units. The affected products are EO sterilized surgical convenient packs packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall is being issued because the compromised packaging integrity could result in product contamination or a loss of sterility condition. This poses a potential risk of injury to patients if the products are used in a non-sterile state. 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. Users of these medical devices should stop using the affected lots and contact Customed, Inc. for further instructions or a replacement.
The recalled product
- Product
- LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" LIF ( I) SKIN MARKER INK W/8 LABEL ( I) CAUTERY TIP POLISHER LIF ( I) TUBE SUCTION CONNECT. W' X 12' LIF (6) DRAPE UTILITY W/TAPE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (2) UTILITY BOWL 16o
- 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 900-1202
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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