Z-1330-2018Class II
(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety...
Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-12-22 / Terminated / root cause: manufacturing process
Arrow International Inc began a recall of (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit... on . FDA classified it as Class II and gives the reason as "Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1330-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Arrow International LLC (subsidiary of Teleflex Incorporated)
- Product
- (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A
- Product code
- DQX Wire, Guide, Catheter
- Reason for recall
- Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- The notification letter includes the following instructions for CUSTOMERS: 1. Discontinue use and quarantine any affected products. 2. Complete and return the Recall Acknowledgement Form to start return process. 3. Complete the Recall Acknowledgment Form if there is no product on hand. Instructions for DISTRIBUTORS: 1.Discontinue distribution and quarantine any affected products. 2. Communicate this recall to any customers with affected product. 3. Have the customers return any affected product to you with a completed Recall Acknowledgement Form. 4. Return affected products from inventory using the Recall Acknowledgement Form. 5. Once you have returned recalled products from your own inventory, and collected the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and return the form.
- Distribution
- Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
- Product codes and lots
- Lot Numbers: (1) 13F17D0198, 13F17F0215; (2) 13F17E0029, 13F17E0537; (3) 13F17B0226, 13F17D0017, 13F17D0280; (4) 13F17A0122, 13F17C0342, 13F17E0364, 13F17E0827
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1323-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1324-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1325-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1326-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1327-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1328-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1329-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1330-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1331-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1332-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1333-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1334-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1335-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1336-2018 | Class II | Terminated | Voluntary: Firm initiated |
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