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.
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 (injury due to contamination or loss of sterility) in a medical device, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 20 lots of Neuro Spine Packs, totaling 800 units, due to a potential compromise in packaging integrity. The affected product is an EO sterilized surgical convenient pack containing various surgical instruments and supplies, packaged in a polyester/polyethylene breather bag with Tyvek double vents.
The recall is being issued because the compromised packaging could result in product contamination or a loss of sterility condition. This poses a risk of injury to patients who use the products during surgical procedures.
The affected lots 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. Users should stop using the affected products and contact Customed, Inc. for instructions on return or replacement.
The recalled product
- Product
- NEURO SPINE PACK - (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90" (4) ABSORBENT TOWELS 15" X 20" UF (1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP (1) DURAPREP SURGICAL SOLUTION 26mL UF (1
- 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 900-1300
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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