Z-1345-2016Class II

NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No...

Name: Z-1345-2016 NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No...
Creator: AngioDynamics Inc.
Published: 2015-11-03
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2015-11-03 / Terminated / root cause: manufacturing process

FDA source

AngioDynamics Inc. began a recall of NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is intended... on 2015-11-03. FDA classified it as Class II and gives the reason as "Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as...". 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-1345-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-03
Posted: 2016-04-07
Terminated: 2017-03-16
Recalling firm: Boston Scientific Corporation
Product: NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036".
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On November 03, 2015, Navilyst Medical distributed Urgent Voluntary Medical Device Recall notices to their customers via courier service. Customers were advised to immediately remove the recall product from inventory and to segregate the products in a secure location for return to AngioDynamics, Inc. Customers should immediately forward a copy of the recall notification letter to all sites if these products were further distributed. If affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday EST) to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return). The Reply Verification Tracking form can be submitted via fax to: Attn: Convenience Kits - Procedure Products Needles 1-800-782-1357 or via email to [email protected] or [email protected].
Quantity in commerce: 8 kits
Distribution: US Nationwide in the states of CA, IL, MA, SC, TX
Product codes and lots: Batch/Lo. 4925662 Use By 2017-02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1345-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1343-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-07
Z-1344-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-07
Z-1345-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-07
Z-1346-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-07

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)