Z-0051-2007

Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc- 27x1-1/4 A)...

Name: Z-0051-2007 Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc- 27x1-1/4 A)...
Creator: Kendall a Division of Tyco Healthcare Group LP
Published: 2006-09-11
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-09-11 / Terminated

FDA source

Kendall a Division of Tyco Healthcare Group LP began a recall of Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc- 27x1-1/4 A) Product # 8881513744 on 2006-09-11. The reason FDA records is "Incorrect needle: There is an incorrect needle configuration on the syringe. The correct needle has a 27 gage A-bevel, the needle on the syringe has no bevel, typically used for dental irrigation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0051-2007
Status: Terminated
Initiated: 2006-09-11
Posted: 2006-10-21
Terminated: 2009-09-11
Recalling firm: Medtronic, Inc.
Product: Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc- 27x1-1/4 A) Product # 8881513744
Product code: FMF Syringe, Piston
Reason for recall: Incorrect needle: There is an incorrect needle configuration on the syringe. The correct needle has a 27 gage A-bevel, the needle on the syringe has no bevel, typically used for dental irrigation.
FDA root cause: Other
Action: A recall letter was mailed 9/12/2006 to the 44 customers who purchased this product from Tyco Healthcare. The firm requested that their distributors notify their customers, and coordinate recovery of the product. The recall mailing included a form that was to be faxed back to Tyco Healthcare. A postage paid return envelope was also included if the customer does not have access to a fax machine.
Quantity in commerce: 130,000
Distribution: Nationwide
Product codes and lots: Lot Numbers: 611406 and 611407

Product code FMF

K852544Class IIMonoject Sterile 3Cc Syringes W/ & Wo/ NeedlesSherwood Medical Co. / cleared 1985-07-23

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)