Z-2670-2017Class II

Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB...

Name: Z-2670-2017 Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB...
Creator: Smiths Medical ASD Inc.
Published: 2017-04-04
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-04-04 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO on 2017-04-04. FDA classified it as Class II and gives the reason as "Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2670-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-04
Posted: 2017-07-03
Terminated: 2019-08-05
Recalling firm: Abbott Medical
Product: Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming inspection. The syringe assemblies were used to manufacture seven (7) finished good lots of Hypodermic Needle Pro needles, Smiths Medical part numbers EL 1915 and SB5021.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Smiths Medical sent an "Urgent Medical Device Recall Notice" dated April 04, 2017. The letter was addressed to Quality Assurance Manager & Associate Sourcing Consultant. The letter listed the Affected devices described the Reason for Recall, & Risk to Health. Requested consignee to complete Urgent Medical Device Recall Response Form within 10 days of receipt and send it to: [email protected]. For further questions, please call (603) 352-3812
Quantity in commerce: 736,000
Distribution: US Distribution to the state of : IN
Product codes and lots: 3297460,3297461 Model No. EL1915. 3297458,3297459,3297465, 3297466,3297467 Model No. SB5021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2670-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2670-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03

Product code FMI

K923127Class IINeedle-Pro CartridgeConcord/Portex / cleared 1993-04-29

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)