Z-1047-2014Class I

ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060...

Name: Z-1047-2014 ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060...
Creator: Medline Industries, Inc.
Published: 2013-08-14
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2013-08-14 / Terminated / root cause: manufacturing process

FDA source

Medline Industries, Inc. began a recall of ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply... on 2013-08-14. FDA classified it as Class I and gives the reason as "Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc". 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-1047-2014
Classification: Class I
Status: Terminated
Initiated: 2013-08-14
Posted: 2014-02-21
Terminated: 2017-12-19
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
Product code: LRO General Surgery Tray
Reason for recall: Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Medline Industries, Inc., sent a "RECALL IMMEDIATE ACTION REQUIRED" letter dated August 14, 2013, to its direct accounts/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately check their stocks for inventory of the affected products, quarantine any affected products, return the product using the enclosed shipping slips for credit-If additional stickers are needed, please call 866-359-1704, and complete and return the enclosed FAX-BACK VERIFICATION FORM listing the quantity of affected product(s) on hand via fax to Medline at 866-767-1290. If you have any questions, please contact 866-359-1704.
Quantity in commerce: 768 units
Distribution: Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.
Product codes and lots: Pack Number: DYNJ39185; Lots: 13EB2046, 13FB1553, 13GB2605

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1047-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1046-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-1047-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-1048-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-1049-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-1050-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-1051-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-1052-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-1053-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-1054-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-1055-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-1056-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21

Product code LRO

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)