Customed Recalls Carpal Tunnel Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling carpal tunnel surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class I. According to the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Customed, Inc. is recalling specific lots of Carpal Tunnel Surgical Large Packs. The recall involves 360 units across four lots with product code 900-742A. The affected lots are identified by the codes 140312026, 140412702, 140513380, and 140513481.
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 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 lots should stop using the products and contact Customed, Inc. for further instructions on return or replacement. The FDA has classified this as a Class I recall.
The recalled product
- Product
- CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF (1) NEEDLE HYPODERMIC 18G X 1 % LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BOWL UTILITY QUART 32oz. (2) SHEET DRAPE 41" X 58" SMS LIF (2) TOWELS ABSORBENT 15" X 20" LIF (1) BANDAGE GAUZE STRETCH 4"
- 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 900-742A
- 4 lots: 140312026 140412702 140513380 140513481
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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