Z-1789-2017Class II
ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc. / initiated 2017-03-16 / Terminated / root cause: manufacturing process
Windstone Medical Packaging, Inc. began a recall of ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure on . FDA classified it as Class II and gives the reason as "AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1789-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure
- Product code
- FSY Light, Surgical, Ceiling Mounted
- Reason for recall
- AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- AMS sent an Urgent Medical Device Recall letter dated March 16, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit. Customers should check inventory and complete the Recall Reply Form. Fax the completed form to Aligned Medical Solutions at 407-804-8460 or email the completed form to [email protected]. Customers can call Aligned Medical Solutions at 321-527-7714.
- Quantity in commerce
- 16 kits
- Distribution
- Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
- Product codes and lots
- Lot numbers: 72702 and 78567
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1783-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1784-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1785-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1786-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1787-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1788-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1789-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1790-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1791-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1792-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1793-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1794-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1795-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1796-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1797-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1798-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1799-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1800-2017 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.