Customed Recalls Hair Restoration Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Hair Restoration Packs (code 900-2966) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (loss of sterility/contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Customed, Inc. has initiated a recall of Hair Restoration Packs, code 900-2966. The recalled product consists of EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The specific items included in the pack are: (1) Mayo Stand Cover 23x54, (2) Towel Cloth Huck Blue, (2) Table Cover Back Zone Reinforced 44 x 90, (2) Gown Soft SMS Std. X-Large AAMI III, (2) Towel Absorbent 15 x 20, and (1) Minde Knife 1.0mm, Wide, 40 Degree Angle, 6.0mm in Length.
The recall is being conducted because Customed has determined that there is a possibility that packaging integrity may be compromised on different catalog numbers across multiple lots. This potential compromise could result in an injury to the patient due to product contamination or the loss of the product's sterility condition.
The recall involves 2 lots (lot numbers 131210948 and 140613794) totaling 72 units. The products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and the US Virgin Islands/St. John) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Users should stop using the affected products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Hair Restoration Pack- , code 900-2966, contains: (1) MAYO STAND COVER 23X54 (2) TOWEL CLOTH HUCK BLUE (2) TABLE COVER BACK ZONE REINFORCED 44 X 90 (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (2) TOWEL ABSORBENT 15 X 20 (1) MINDE KNIFE 1.0MM, WIDE, 40 DEGREE ANGLE, 6.0MM IN LEN
- 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)
- Code 900-2966
- 2 lots: 131210948 140613794
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.
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