FDA Medical Device Recalls (openFDA)
Medline Industries, Inc.: CATH TRAY; REF: DYNJ41101; 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.
- Recall number
- Z-1050-2014
- Recalling firm
- Medline Industries, Inc.
- Product
- CATH TRAY; REF: DYNJ41101; 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.
- Status
- Terminated
- Initiated
- 2013-08-14
- Posted
- 2014-02-21
- Terminated
- 2017-12-19
- Reason
- 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
- 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
- 304 units
- Distribution
- Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.
- Lot, serial or model codes
- Pack Number: DYNJ41101; Lot: 13FB5744
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 3000717925
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28