Z-1356-2017Class II
Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pacemaker Kit, part number AMS4281(C...
Windstone Medical Packaging, Inc. / initiated 2017-01-11 / Terminated / root cause: manufacturing process
Windstone Medical Packaging, Inc. began a recall of Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pacemaker Kit, part number AMS4281(C Pacemaker Kit, part number AMS4281(D 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-1356-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pacemaker Kit, part number AMS4281(C Pacemaker Kit, part number AMS4281(D
- 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
- 561 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 80492, 5/3/2018 82502, 6/8/2018 85302, 7/12/2018 88153, 11/13/2018 89116, 12/10/2018 89318, 11/22/2018 95070, 1/29/2019 95088, 11/14/2018 95580, 1/4/2019 95581, 1/4/2019 95582, 1/11/2019 95583, 1/24/2019 97115, 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.