Customed Recalls Liposuction Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling liposuction 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 specific lots of Liposuction Packs for Aesthetic Surgical Centers. The recall involves 2 lots totaling 32 units, identified by product code 900-2290 and lot numbers 112030728 and 112041301. The packs contain various surgical items, including blades, gloves, sponges, and drapes, and are EO sterilized.
The recall was initiated because Customed determined there is a possibility that packaging integrity may be compromised. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The affected products were distributed worldwide, including in the United States (nationwide, specifically Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
Healthcare facilities and consumers who have these specific liposuction packs should stop using them immediately. They should contact Customed, Inc. for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- LIPOSUCTION PACK AESTHETIC SURG.CENTER CONTENTS: (1) BLADE SURG. #11 CARBON STEEL (3) * GLOVE PERRY SURG. # 7LATEX (15) SPONGE LAP PREWASH 18" X 18" XRD L/F (4) * GLOVE PERRY SURG. # 7 LATEX (1) TABLE COVER REINF 50" X 90" LIF (2) GOWN SOFT SMS STD XL SET IN SLEEVE L/F (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 900-2290
- 2 lots 112030728 112041301
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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