Z-2038-2019Class II

Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037

Name: Z-2038-2019 Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037
Creator: Cardinal Health 200, LLC
Published: 2019-04-30
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-04-30 / Completed / root cause: sterility

FDA source

Cardinal Health 200, LLC began a recall of Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037 on 2019-04-30. FDA classified it as Class II and gives the reason as "Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2038-2019
Classification: Class II
Status: Completed
Initiated: 2019-04-30
Posted: 2019-07-23
Recalling firm: Medtronic, Inc.
Product: Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Cardinal Health issued notification letter by mail on 4/30/19 advising product defect, health risk and action to take: 1. INSPECT inventory for the affected 2. SEGREGATE and QUARANTINE all on-hand product; 3. RETURN acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product quarantined or discarded. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST. Questions contact Cardinal Health at 800-292-9332
Distribution: Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
Product codes and lots: Lot Number:904212, 905612, 907002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2038-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2036-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2037-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2038-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2039-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2040-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2041-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2042-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2043-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2044-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2045-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2046-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2047-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2048-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2049-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2050-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2051-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2052-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-23

Product code FMI

K854547Class IIMonoject Sterile M200 Aluminum/m250 PolypropyleneSherwood Medical Co. / cleared 1986-02-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)