Z-1341-2017Class II
Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor...
Windstone Medical Packaging, Inc. / initiated 2017-01-11 / Terminated / root cause: manufacturing process
Windstone Medical Packaging, Inc. began a recall of Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number... 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-1341-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(A
- 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
- 665 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 100188, 10/19/2019 100884, 9/17/2019 84683, 5/27/2018 85122, 6/3/2018 85476, 8/17/2018 85717, 7/21/2018 86693, 9/3/2018 8695212/2/2018 87882, 11/11/2018 88612, 12/28/2018 88934, 11/28/2017 89105, 10/2/2018 89214, 11/19/2018 89473, 1/2/2019 89751, 1/21/2019 95234, 1/7/2019 96087, 1/9/2019 97240, 4/5/2018 97339, 5/13/2019 97525, 6/19/2019 97802, 6/10/2018 97958, 6/4/2019 98056, 6/29/2019 98591, 6/30/2019 99911, 9/24/2019 99918, 6/20/2019
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.