Customed Recalls Face Pack Aesthetic Surgery Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling 96 units of Face Pack Aesthetic Surgery kits 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 source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4. The hazard involves loss of sterility and potential contamination, which is a significant injury risk.
Plain-English summary
Customed, Inc. is recalling 96 units of Face Pack Aesthetic Surgery kits, comprising 2 lots (product code 900-2291, lot numbers 112010139 and 112020467). The recall was initiated because the company determined that packaging integrity may be compromised on different catalog numbers. The kits contain various surgical supplies, including applicators, gauze sponges, needles, towels, syringes, blades, gloves, and drapes, which are EO sterilized and packaged in polyester/polyethylene breather bags with Tyvek double vents.
The compromised packaging integrity could result in product contamination or loss of sterility condition, which poses a risk of injury to the patient. 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 providers should stop using the affected Face Pack Aesthetic Surgery kits and contact Customed, Inc. for further instructions or a return. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- FACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR COTION 6" WOOD (60) GAUZE SPONGE 4" X 4" 16 PLY SOFT LIF (2) NEEDLE SPINAL ANEST 22G X 3 Y2 LIF (8) TOWELS CLOTH HUCK BLUE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (6) BLADE #15…
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Kits
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 900-2291
- 2 lots 112010139 112020467
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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