Customed Recalls Ortho Implant Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Ortho Implant 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 (sterile surgical pack) where injury has not yet been reported, fitting the High severity criteria for potential contamination or loss of sterility.
Plain-English summary
Customed, Inc. is recalling specific lots of Ortho Implant Surgical Packs. The recall involves 153 units across two lots, identified by product code 900-741A and various lot numbers including 140412701 and 112104102.
The recall was initiated because Customed determined that the packaging integrity of these surgical packs may be compromised. This defect could result in product contamination or a loss of sterility, which poses a risk of injury to patients. The affected products are EO sterilized surgical convenient packs packaged in polyester/polyethylene breather bags with Tyvek double vents.
The affected units were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Healthcare facilities and consumers who have these specific lots should stop using the products and contact Customed, Inc. for further instructions or a return.
The recalled product
- Product
- ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z" (1) TUBE SUCTION CONNECT. }4" X 12' (1) DURAPREP SURGICAL SOLUTION 26ml (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE
- 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 900-741A
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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