Z-2020-2015Class II
Stradi 4500 - contains Devon Light Glove Used during surgery
Gyn-Disposables, Inc. / initiated 2015-04-20 / Completed / root cause: manufacturing process
Stradis Healthcare, LLC. began a recall of Stradi 4500 - contains Devon Light Glove Used during surgery on . FDA classified it as Class II and gives the reason as "Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits". As of , the recall status on record is Completed, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2020-2015
- Classification
- Class II
- Status
- Completed
- Initiated
- Posted
- Recalling firm
- Gyn-Disposables, Inc.
- Product
- Stradi 4500 - contains Devon Light Glove Used during surgery
- Product code
- LRO General Surgery Tray
- Reason for recall
- Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to [email protected]. Customers with questions regarding return of the product should call 1-727-642--4124.
- Quantity in commerce
- 1
- Distribution
- Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
- Product codes and lots
- Pack 682-1102
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1992-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1993-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1994-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1995-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1996-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1997-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1998-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1999-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2000-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2001-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2002-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2003-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2004-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2005-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2006-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2007-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2008-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2009-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2010-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2011-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2012-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2013-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2014-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2015-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2016-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2017-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2018-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2019-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2020-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2021-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2022-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2023-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2024-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2025-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2026-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2027-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2028-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2029-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2030-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2031-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2032-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2033-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2034-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2035-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2036-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2037-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2038-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2039-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2040-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2041-2015 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-2042-2015 | Class II | Completed | Voluntary: Firm initiated |
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