Agency classClass IOur severity:Critical FDA (Devices)·Z-2504-2014·Announced 2014-09-10

Customed Recalls Neuro Spine Packs Due to Potential Packaging Integrity Issues

Customed, Inc. is recalling Neuro Spine 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 metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) regardless of other factors.

Plain-English summary

Customed, Inc. is recalling 132 units of Neuro Spine Packs (Code 900-2765) across six lots. The recall is due to a determination that packaging integrity may be compromised on different catalog numbers. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients.

The affected lots are 112124939, 113036441, 113056798, 113057644, 113078320, and 113088806. These 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.

The FDA has classified this recall as Class I, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. Healthcare facilities and consumers should stop using these products and contact the manufacturer for instructions on return or replacement.

The recalled product

Product: NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART (I) Pk. STRIP SURGICAL W' X 6" (I) CAUTERY PENCIL HAND SWITCHING LIF (4) UTILITY DRAPE W/TAPE L/F (I)…
Manufacturer: Customed, Inc
Category: Medical Device — Surgical Packs
Hazard: contamination
loss-of-sterility

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 900-2765
6 lots 112124939 113036441 113056798 113057644 113078320 113088806

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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 →

Same manufacturer · Customed, Inc

See all →

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Same hazard · contamination