Z-1320-2017Class II
Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy...
Windstone Medical Packaging, Inc. / initiated 2017-01-11 / Terminated / root cause: manufacturing process
Windstone Medical Packaging, Inc. began a recall of Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860 on . FDA classified it as Class II and gives the reason as "The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1320-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860
- Product code
- FSY Light, Surgical, Ceiling Mounted
- Reason for recall
- The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- AMS notified their consignees by Email, Fax, and Phone on 11/11/2017. AMS sent the notification letter, dated January 11, 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 with questions can call Vicki Davis at 321-527-7714 or send email to [email protected].
- Quantity in commerce
- 700 kits
- Distribution
- Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
- Product codes and lots
- Lot number and expiration date 100023, 9/22/2019 100595, 9/1/2019 84529, 5/13/2018 84584, 5/26/2018 84728, 5/25/2018 85250, 7/22/2018 85273, 7/10/2018 85645, 8/1/2018 85845, 8/19/2018 87286, 8/11/2019 87350, 9/21/2018 87967, 9/24/2018 88173, 11/11/2018 88390, 11/21/2018 88627, 12/24/2018 89082, 10/3/2018 89422, 12/16/2018 89511, 11/13/2018 94573, 11/19/2018 94941, 11/20/2018 95452, 5/6/2019 95985, 3/8/2019 97273, 5/22/2019 98169, 6/26/2019 98664, 6/25/2019 98675, 6/23/2019 99375, 6/12/2019
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1258-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1259-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1260-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1261-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1262-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1263-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1264-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1265-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1266-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1267-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1268-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1269-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1270-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1271-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1272-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1273-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1274-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1275-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1276-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1277-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1278-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1279-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1280-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1281-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1282-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1283-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1284-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1285-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1286-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1287-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1288-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1289-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1290-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1291-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1292-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1293-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1294-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1295-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1296-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1297-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1298-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1299-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1300-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1301-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1302-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1303-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1304-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1305-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1306-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1307-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1308-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1309-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1310-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1311-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1312-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1313-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1314-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1315-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1316-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1317-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1318-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1319-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1320-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1321-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1322-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1323-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1324-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1325-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1326-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1327-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1328-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1329-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1330-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1331-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1332-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1333-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1334-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1335-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1336-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1337-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1338-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1339-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1340-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1341-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1342-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1343-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1344-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1345-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1346-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1347-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1348-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1349-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1350-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1351-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1352-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1353-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1354-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1355-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1356-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1357-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1358-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1359-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1360-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1361-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1362-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1363-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1364-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1365-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1366-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1367-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1368-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1369-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1370-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1371-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1372-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1373-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1374-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1375-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1376-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1377-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1378-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1379-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1380-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1381-2017 | 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.