Zee Clear Vinyl Medical Examination Gloves, Powder Free, Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Dist

FDA device recall Z-0680-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Cypress Medical Products LLC

Reason for recall

The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.

Action taken

Cypress Medical telephoned the accounts and then sent Urgent Voluntary Medical Device Recall letters dated November 14, 2011, to all affected customers. The letter informed them that the lot of gloves did not meet certain release specifications and that some of the gloves may not provide an effective barrier to infectious material. Customers were requested to cease distribution of the affected product, quarantine the gloves, and contact Cypress Medical's customer service department at 800-334-3646 for a returned goods authorization, return instruction and credit. The accounts were also requested to notify their customers of the recall, and to complete and return the enclosed reply form. For questions regarding this recall call 815-385-0100.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LYZ

Quantity affected

240 cases

Distribution

Nationwide Distribution including California, Indiana, New York and Texas

Date initiated

2011-11-15

Date posted

2012-01-11

Date terminated

2012-10-08

Location

Mchenry, IL

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