Z-1269-2017Class II
Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519
Windstone Medical Packaging, Inc. / initiated 2017-01-11 / Terminated / root cause: manufacturing process
Windstone Medical Packaging, Inc. began a recall of Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519 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-1269-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519
- 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
- 276 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 101418, 10/9/2019 84727, 5/25/2018 85308, 6/3/2018 85485, 8/5/2018 86644, 9/11/2018 87420, 9/14/2018 88160, 11/15/2018 89015, 10/8/2018 89570, 12/1/2018 94914, 1/21/2019 94920, 1/12/2019 95736, 1/2/2019 96290, 1/28/2019 96902, 8/16/2020 99041, 9/25/2019
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.