Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 20 lots of arthroscopy 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 packs) where injury has not yet been reported, fitting the 'High' severity criteria for potential contamination or loss of sterility.
Plain-English summary
Customed, Inc. has initiated a recall of 20 lots of arthroscopy packs, totaling 1,356 units. The recall involves specific surgical kits containing items such as towels, syringes, blades, needles, and drapes, which are EO sterilized and packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall was issued because Customed determined there is a possibility that the packaging integrity may be compromised on these products. This defect could result in an injury to the patient due to product contamination or the loss of the product's sterility condition.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. The specific lot numbers affected are: 112030744, 112041351, 112052010, 112062505, 112072876, 112093641, 112104101, 112114588, 112125111, 113015457, 113025967, 113036380, 113057877, 113088887, 113099452, 113099576, 131110272, 131210839, 140111248, and 140211735. Users should check their inventory for these lot numbers and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BLADE SURGICAL # 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1 ~ LIF (1) TUR Y SET 81
- 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 900-740
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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