Z-0444-2016Class II

Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use...

Name: Z-0444-2016 Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use...
Creator: Myco Medical Supplies Inc
Published: 2015-11-06
License: https://open.fda.gov/license/

Myco Medical Supplies Inc / initiated 2015-11-06 / Terminated

FDA source

Myco Medical Supplies Inc began a recall of Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle on 2015-11-06. FDA classified it as Class II and gives the reason as "Particulates: Complaints of rubber coring from the closure of injection vials". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0444-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-06
Posted: 2015-12-17
Terminated: 2017-05-03
Recalling firm: Myco Medical Supplies Inc
Product: Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Particulates: Complaints of rubber coring from the closure of injection vials.
FDA root cause: Under Investigation by firm
Action: MYCO Medical sent an Advisory Notice dated November 6, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory, if any affected product found MYCO request that the customer return the product to MYCO Medical following the instructions provided on the Materials for Return Form. Customers with questions were instructed to call Customers Service at 919-460-2535/ customerservice&mycomedical.com or cal the Quality Department at 919-460-2535/ [email protected].
Quantity in commerce: 2,401,419 units (100ea/bx, 12bx/cs, 1200ea/cs)
Distribution: Nationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT.
Product codes and lots: Item #02463, Lot numbers: 19351R, 16561M, 17531D, 22541D, 22551D, 25551D and 25551M.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0444-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0444-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-17

Product code FMI

K945225Class IIDisposable Syringes and Disposable NeedlesMyco Medical Supplies, Inc. / cleared 1995-01-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)