Z-0741-2017Class II
McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
Cypress Medical Products LLC / initiated 2016-10-12 / Terminated / root cause: manufacturing process
CYPRESS MEDICAL PRODUCTS began a recall of McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140 on . FDA classified it as Class II and gives the reason as "A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0741-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Cypress Medical Products LLC
- Product
- McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
- Product code
- LYZ Vinyl Patient Examination Glove
- Reason for recall
- A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- A letter, dated October 19, 2016, on Cypress Medical Products letterhead, was sent to customers. Customers were requested to stop use and quarantine the gloves.
- Quantity in commerce
- 2005.2 cases have been distributed
- Distribution
- US Distribution. This recall is limited to one distribution center in Auburn, Washington, and the customers serviced from that distribution center.
- Product codes and lots
- Lot Number: CDZF06-03
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0741-2017 | Class II | Terminated | Voluntary: Firm initiated |
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