Myco Medical Supplies Recalls Unolok Blunt Fill Needles Due to Particulates
Myco Medical Supplies Inc is recalling Unolok Blunt Fill Needles because complaints were received regarding rubber coring from injection vial closures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 medical device with a risk of particulate contamination (rubber coring), which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Myco Medical Supplies Inc is recalling Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needles. The recall is being conducted due to complaints of rubber coring from the closure of injection vials, which indicates the presence of particulates.
The affected product is identified by Item #02463 and includes lot numbers 19351R, 16561M, 17531D, 22541D, 22551D, 25551D, and 25551M. A total of 2,401,419 units were distributed nationwide, including to Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, New Jersey, New York, Nevada, Oklahoma, Pennsylvania, Texas, and Utah.
Consumers and healthcare facilities should stop using the affected needles and contact Myco Medical Supplies Inc for further instructions or a refund.
The recalled product
- Product
- Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
- Manufacturer
- Myco Medical Supplies Inc
- Category
- Medical Device — Needles
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 (7)
- Item #02463
- Lot numbers: 19351R
- 16561M
- 17531D
- 22541D
- 22551D
- 25551D and 25551M.
Distribution
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