Customed Recalls Knee Arthroscopy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 22 lots of Knee Arthroscopy 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 source text explicitly states the agency classification is Class I. According to the severity rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Customed, Inc. is recalling 22 lots of Knee Arthroscopy Packs (Product code 900-2123) due to a potential compromise in packaging integrity. The recalled products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The specific lots affected include 112041293, 112041377, 112051685, 112083162, 112093925, 112104110, 112114603, 113015564, 113026273, 113036460, 113036691, 113078467, 113088788, 113109787, 131110236, 131210645, 140111094, 140211658, 140312117, 140412557, 140513124, and 140613657.
The recall was initiated because Customed determined that the packaging integrity of these products may be compromised. This defect could result in an injury to the patient due to product contamination or the loss of the product's sterility condition. The agency has classified this recall as Class I.
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. A total of 784 units across the 22 lots are involved in this recall. Healthcare facilities and consumers should stop using these products and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- KNEE ARTHROSCOPY PACK CONTENTS: (1) TOWEL ABSORBENT 15" X 20" L/F (10) GAUZE SPONGE 4" X 4" 16PLY (1) SAFETY IV INTROCAN 18 X 1Y. ST. LIF (1) NEEDLE HYPODERMIC 18G X 1Y:z (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) SKIN MARKER INK W/8 LABEL (2) TUBE SUCTION…
- 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 (1)
- Product code 900-2123
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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