Customed Recalls Orthopedic Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling orthopedic 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 is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The hazard involves loss of sterility and potential contamination, which are high-risk factors for surgical instruments, even though no specific injuries are reported in the source text.
Plain-English summary
Customed, Inc. is recalling specific lots of orthopedic surgical packs due to a potential compromise in packaging integrity. The recalled products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The recall involves 7 lots totaling 236 units, with multiple units per lot.
The recall was initiated because the compromised packaging could result in product contamination or a loss of sterility condition. This poses a risk of injury to patients if the products are used in a non-sterile state. 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.
Healthcare facilities and consumers who have these specific orthopedic surgical packs should stop using them immediately. The affected product code is 900-2039. The specific lot numbers involved are 112062199, 113026170, 113057698, 113099418, 131110232, 140311817, and 140312114. Users should contact Customed, Inc. for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X 1 2' LIF (1) BAG GLASSINE (2) LITE GLOVE (1) TABLE COVER BTC 77" X 11 0" HD FULL COVERAGE LIF (1) MAYO STAND COVER R
- 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 900-2039
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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