Recall Z-1204-2024— Parker Laboratories, Inc.

Name: FDA recall Z-1204-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-22

Class II · Ongoing

Class II FDA medical device recall by Parker Laboratories, Inc., initiated 2024-01-22. It names one FDA 510(k) clearance: K852956. Product: Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.. Reason: Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60..

Recalling firm: Parker Laboratories, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-01-22
Firm location: Fairfield, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K852956 — CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITIONParker Laboratories, Inc.·cleared 1985-08-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.

Reason for recall

Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.

Data sourced from openFDA. This site is unofficial and independent of the FDA.