FDA (Devices) recall action 66080

Medline Industries, Inc. recalled 11 products on 2014-03-05

The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2014-03-05
Critical: 0
Units: 2,853

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–11 of 11

SevereFDA (Devices)··2014-03-05
Medline Recalls Surgical Kits With Flaking Guidewire Coating
Medline Industries is recalling 304 surgical kits containing guidewires with a potential for coating to flake off.
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.
Category
Distribution
7 states
SevereFDA (Devices)··2014-03-05
Medline Recalls Angiography Packs Due to Guidewire Coating Flaking Risk
Medline Industries is recalling 1,194 angiography packs because a guidewire component may have flaking coating. The recall covers distribution in seven US states.
Product
ANGIOGRAPHY PACK; REF: DYNJ26855D; 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.
Category
Distribution
7 states
SevereFDA (Devices)··2014-03-05
Medline Recalls Heart Catheter Kits Due to Coating Defect
Medline Industries is recalling 160 Heart Cath Custom Packs because a guidewire component may have a flaking coating.
Product
HEART CATH CUSTOM PACK; REF: DYNJ39747A; 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.
Category
Distribution
7 states
SevereFDA (Devices)··2014-03-05
Medline Recalls Surgical Kits with Flaking Guidewire Coating
Medline Industries is recalling five surgical kits containing a guidewire with a potential coating flake-off defect.
Product
STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Category
Distribution
7 states
SevereFDA (Devices)··2014-03-05
Medline Recalls Angiography Surgical Kits Due to Guidewire Coating Defect
Medline Industries is recalling 120 surgical kits containing guidewires with a potential coating flaking defect.
Product
CATH PACK; REF: DYNJ41103; 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.
Category
Distribution
7 states
SevereFDA (Devices)··2014-03-05
Medline Recalls Cath Lab Custom Packs Due to Guidewire Coating Defect
Medline Industries is recalling 120 Cath Lab Custom Packs because the guidewire coating may flake off. The kits were distributed nationwide to specific states.
Product
CATH LAB CUSTOM PACK; REF: DYNJ40926; 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.
Category
Distribution
7 states
SevereFDA (Devices)··2014-03-05
Medline Recalls Sterile Sample Cath Lab Packs Due to Coating Defect
Medline Industries is recalling 10 units of Sterile Sample Cath Lab Packs because a guidewire component has a potential for its coating to flake off.
Product
STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Category
Distribution
7 states
SevereFDA (Devices)··2014-03-05
Medline Recalls Angiography Drape Packs Due to Guidewire Coating Defect
Medline Industries is recalling 50 units of CATH ANGIOGRAPHY DRAPE PACKS because a guidewire inside the kits has a potential for its coating to flake off.
Product
CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Category
Distribution
7 states
SevereFDA (Devices)··2014-03-05
Medline Recalls Surgical Kits with Flaking Guidewire Coating
Medline Industries is recalling 112 surgical kits containing guidewires with a potential for coating to flake off.
Product
CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Category
Distribution
7 states
SevereFDA (Devices)··2014-03-05
Medline Recalls Angio Pack #2 Surgical Kits Due to Coating Defect
Medline Industries is recalling 768 units of Angio Pack #2 surgical kits because a guidewire component has a potential for its coating to flake off.
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.
Category
Distribution
7 states
SevereFDA (Devices)··2014-03-05
Medline Recalls Surgical Kits with Potential Coating Defect on Guidewires
Medline Industries is recalling 10 surgical kits containing guidewires with a potential coating defect. The kits were distributed to specific US states.
Product
STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures..
Category
Distribution
7 states