The Recall Desk
HighFDA (Devices)·Z-0444-2016·Announced 2015-12-23

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.

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 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

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

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Same manufacturer · Myco Medical Supplies Inc

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