Recall Z-0162-2018— Medline Industries Inc

Name: FDA recall Z-0162-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-23

Class II · Terminated

Class II FDA medical device recall by Medline Industries Inc, initiated 2017-10-23, terminated 2021-04-06. It names one FDA 510(k) clearance: K040503. Product: Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.. Reason: Possible open seal on top portion of the package. Could cause breach of sterility..

Recalling firm: Medline Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2017-10-23
Terminated: 2021-04-06
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K040503 — ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOURWrp Asia Pacific Sdn. Bhd.·cleared 2004-03-16

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

Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.

Reason for recall

Possible open seal on top portion of the package. Could cause breach of sterility.

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