Z-1164-2015Class II
NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE, Rx ONLY --- For...
Boston Scientific Corporation / initiated 2015-01-09 / Terminated / root cause: packaging
Navilyst Medical, Inc began a recall of NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588... on . FDA classified it as Class II and gives the reason as "The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has...". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1164-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Boston Scientific Corporation
- Product
- NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
- Product code
- OEZ Cardiovascular Procedure Kit
- Reason for recall
- The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has been breached, may result in an increased risk of infection.
- Root cause tag
- packaging
- FDA root cause
- Packaging
- Action
- Navilyst Medical sent an Urgent Medical Device Recall Notification letter dated January 9, 2015 to US customers (end users) via Federal Express. On January 20, 2015, Recall Notification Packages were sent via Federal Express to 2 International consignees (distributors). the letter identified the affected product, problem and actions to be taken. Customers are instructed to: " Immediately remove the recall product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). " Segregate this product in a secure location for return to Navilyst Medical. " Immediately forward a copy of this recall notification to all sites to which you have distributed affected product. " Complete and return the Reply Verification Tracking Form.
- Quantity in commerce
- 602 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
- Product codes and lots
- Lots 4249077, 4269176, 4279293, 4309514, 4344291, 4357820, 4374582, 4397278, 4408802, 4413652, 4417802, 4437356, 4446935, 4448734, 4475767, 4505455, 4508682, 4534876, 4549032, 4573232, 4603970, 4612729, 4613703, 4623930, 4640696, 4641242, 4650060, 4650061, 4654980, 4662133, 4665914, 4672429, 4672430, 4680371, 4682826, 4690910, 4691429, 4696900, 4704415, 4712996, 4722861, 4730922, 4735734, 4742076, 4742077, 4751114, 4764646, 4771431, 4780605, 4786234, 4798124, 4808876, 4812348, 4814046, 4819811, 4831349.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1148-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1149-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1150-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1151-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1152-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1153-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1154-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1155-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1156-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1157-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1158-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1159-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1160-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1161-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1162-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1163-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1164-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1165-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1166-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1167-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1168-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1169-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1170-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1171-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1172-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1173-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1174-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1175-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1176-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1177-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1178-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1179-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1180-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1181-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1182-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1183-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1184-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1185-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1186-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1187-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1188-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1189-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1190-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1191-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1192-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1193-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1194-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1195-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1196-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1197-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1198-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1199-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1200-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1201-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1202-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1203-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1204-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1205-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1206-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1207-2015 | 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.