FDA (Devices) recall action 61982

Unimed Surgical Products, Inc. recalled 11 products on 2012-09-05

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: 2012-09-05
Critical: 0
Units: 25,440

Why these products were recalled

On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.

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

HighFDA (Devices)··2012-09-05
Medline Extended PTFE Needle Recall for Sterility Concerns
Unimed Surgical Products is recalling Medline Extended PTFE Needles due to sterility concerns. The recall affects 1,440 units distributed nationwide.
Product
Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline
Category
Distribution
1 state
HighFDA (Devices)··2012-09-05
Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to concerns regarding sterility. The affected products are intended for cutting and coagulation of soft tissue.
Product
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
Category
Distribution
1 state
HighFDA (Devices)··2012-09-05
Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units were distributed nationwide in the US.
Product
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a
Category
Distribution
1 state
HighFDA (Devices)··2012-09-05
Unimed Recalls Medline Electrosurgical Needles Due to Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical needles due to concerns about sterility. The affected lot is distributed nationwide.
Product
Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
Category
Distribution
1 state
HighFDA (Devices)··2012-09-05
Medline PTFE Coated Needle Recall Due to Sterility Concerns
Unimed Surgical Products is recalling Medline Standard PTFE Coated Needles due to sterility concerns. The affected lots are distributed nationwide.
Product
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
Category
Distribution
1 state
HighFDA (Devices)··2012-09-05
Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units are intended for cutting and coagulation of soft tissue.
Product
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a
Category
Distribution
1 state
HighFDA (Devices)··2012-09-05
Medline Electrosurgical Electrodes Recalled for Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units are intended for cutting and coagulation of soft tissue.
Product
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is
Category
Distribution
1 state
HighFDA (Devices)··2012-09-05
Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling specific lots of Medline electrosurgical electrodes due to concerns regarding sterility.
Product
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a
Category
Distribution
1 state
HighFDA (Devices)··2012-09-05
Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling specific lots of Medline electrosurgical electrodes due to concerns regarding sterility.
Product
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is
Category
Distribution
1 state
HighFDA (Devices)··2012-09-05
Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to concerns about sterility. The recall affects 1,920 units distributed nationwide.
Product
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
Category
Distribution
1 state
HighFDA (Devices)··2012-09-05
Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected lot is 052709-01.
Product
Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
Category
Distribution
1 state