Customed Recalls Lumbar Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 280 units of Lumbar Packs for Advanced Ambulatory Surgical Centers because packaging integrity may be compromised, risking loss of sterility.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class I recall, and the rubric mandates a score of at least 4 for FDA Class I recalls involving risk of harm.
Plain-English summary
Customed, Inc. is recalling 280 units of Lumbar Packs intended for use in Advanced Ambulatory Surgical Centers. The recall involves five specific lots (112083036, 112125074, 113026297, 113057619, and 113078727) of product code 900-2284. These surgical packs contain various sterile items, including covers, syringes, towels, gauze, scalpels, and drapes, packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because Customed determined there is a possibility that the packaging integrity may be compromised on these lots. This defect could result in product contamination or a loss of sterility, which poses a risk of injury to patients. The agency has classified this recall as Class I.
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. Consumers and healthcare facilities should stop using these specific lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" UF (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (8) TOWELS CLOTH HUCK BLUE UF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) STRIP…
- 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 900-2284
- 5 lots 112083036 112125074 113026297 113057619 113078727
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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