Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling specific lots of Laparoscopy Pack I surgical packs because packaging integrity may be compromised, potentially leading to product contamination or 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 recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility…"
Plain-English summary
Customed, Inc. has initiated a recall of its Laparoscopy Pack I (4) surgical packs. The recall involves two specific lots, identified by codes 112051964 and 113078524, totaling 612 units. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The recall was issued because Customed determined there is a possibility that the packaging integrity of these packs may be compromised. If the packaging is not intact, it could result in product contamination or a loss of the sterile condition, which poses a risk of injury to patients.
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. Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected products if found.
The recalled product
- Product
- LAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15" X 20" LIF (2) LEGGINGS W/7'' CUFF 30" X 42" LIF (1) DRAPE UTILITY WITAPE L/F (1) SUTURE BAG FLORAL LIF (1) SHEET T LAPAROSCOPY SOFT 97" X 96" X 36 LIF" (1) TABLE COVER REINFORCED 44" X 78" L/F…
- 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 900-2485
- 2 lots 112051964 113078524
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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