Customed Recalls Endoveneous Custom Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 12 lots of Endoveneous Custom 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
Customed, Inc. is recalling 12 lots of Endoveneous Custom Packs, product code 900-1937. The recall involves 190 units distributed worldwide, including the United States (nationwide, specifically Florida, Puerto Rico, and USVI) and several international locations such as Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
The company determined that there is a possibility that packaging integrity may be compromised on these catalog numbers. This defect could result in an injury to the patient due to product contamination or loss of sterility condition. The affected lots are identified by the following lot numbers: 111082312, 111113057, 112020431, 112051902, 112062289, 113025829, 113026168, 113067902, 113088773, 131210660, 140211699, and 140312423.
The U.S. Food and Drug Administration has classified this as a Class I recall. Healthcare facilities and consumers should stop using these products and contact the manufacturer for further instructions or returns.
The recalled product
- Product
- ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (3) GOWN SMS X-LARGE STD NON REINFORCED ( 1) TABLE COVER 44" X 90" (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 (1)
- Product code 900-1937
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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