Customed Recalls Laparoscopy Cholecystectomy Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 40 units of laparoscopy cholecystectomy 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. is recalling 40 units of Laparoscopy Cholecystectomy Surgical Packs (Product Code 900-576A) from two specific lots (140312024 and 140513373). The recall is due to a determination that packaging integrity may be compromised on these items. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The compromised packaging integrity could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The recall covers units distributed worldwide, including the United States (nationwide, specifically Florida, Puerto Rico, and USVI) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
Healthcare facilities and consumers who have these specific lots of surgical packs should stop using them immediately and contact Customed, Inc. for instructions on return or disposal. The recall number is Z-2334-2014.
The recalled product
- Product
- LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP (1) BLADE SURGICAL #11 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) GOWN XLARGE SMS IMPERV.…
- 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 900-576A
- 2 lots: 140312024 140513373
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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