Z-0111-05

Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 5551822215

Name: Z-0111-05 Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 5551822215
Creator: Kendall Healthcare Products Co
Published: 2004-10-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-10-08 / Terminated

FDA source

Kendall Healthcare Products Co began a recall of Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 5551822215 on 2004-10-08. The reason FDA records is "Needle cannula may separate from the hub during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0111-05
Status: Terminated
Initiated: 2004-10-08
Posted: 2004-11-02
Terminated: 2012-05-15
Recalling firm: Medtronic, Inc.
Product: Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 5551822215
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Needle cannula may separate from the hub during use
FDA root cause: Other
Action: Recall letters requesting product return were mailed to all customers on October 8, 2004
Distribution: Nationwide
Product codes and lots: Lot numbers in the range of 406100 through 424600 (inclusive)

Product code FMI

K012736Class IIMonoject Safety NeedleTyco Healthcare / cleared 2001-10-25

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)