Z-1784-2017Class II
Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a...
Windstone Medical Packaging, Inc. / initiated 2017-03-16 / Terminated / root cause: manufacturing process
Windstone Medical Packaging, Inc. began a recall of Cataract Kit - Dr. Slingsby, part number CMP1017(B. 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-1784-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Cataract Kit - Dr. Slingsby, part number CMP1017(B. 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
- 990 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: 77429 79999 81143 81960 84055 84556 85169 85550 86501 87632 87819 96056 96963 97873 98741 99416 99763 100278 101449
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 |
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