Z-1790-2017Class II
Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 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 Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 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-1790-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 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
- 1,520 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: 62980 63106 63387 63825 63826 64186 64490 64584 65937 75122 75329 77010 77089 77480 77664 78265 78312 78499 79042 79211 79944 79945 80709 80994 82316 82537 82538 82931
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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