Recall Z-1244-2020
Arrow International Inc · initiated December 20, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Arrow EPIDURAL NEEDLE COMPONENT AN-05505
Codes / lots: Lot Number: 13F18H0836 13F17L0441 13R17L0441
Reason for recall
Product lidstock contains the incorrect expiration date for the product
FDA-determined cause: Incorrect or no expiration date
Action taken
Arrow issued Urgent Medical Device Notification dated 12/20/19 stating reason for recall, health risk and action take: 2. Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex. If an alternative approach is needed, contact Teleflex Customer Service for more information at 1-866-396-2111. 4. To return affected products from your inventory, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex. 5. Once you have completed returning all the recalled products from your own inventory and collecting and consolidating all 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 fax it to 1-855-419-8507, Attn: Customer Service, or email it to recalls@teleflex.com. This will allow us to document completion of the recall. 6. If you and your customers have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Foreign consignees,are notified through the international office.
Details
- Recall number
- Z-1244-2020
- Initiated
- December 20, 2019
- Terminated
- February 25, 2021
- Product code
- CAZ – Anesthesia Conduction Kit
- Quantity
- 1839
- Distribution
- Nationwide Foreign: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA
- Recalling firm
- Arrow International Inc, Reading, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1236-2020 Class II | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1Product lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1237-2020 Class II | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSCProduct lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1238-2020 Class II | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CANProduct lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1239-2020 Class II | Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WHProduct lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1240-2020 Class II | Arrow Maximal Barrier Drape ASK-00002-1AProduct lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1241-2020 Class II | Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1Product lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1242-2020 Class II | Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPMProduct lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1243-2020 Class II | Arrow Central Venous Catheterization Kit ASK-04200-UPMProduct lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1245-2020 Class II | Arrow EPIDURAL CATHETERIZATION KIT AK-05000Product lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1246-2020 Class II | Arrow EPIDURAL CATHETERIZATION KIT YC-02220Product lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1247-2020 Class II | Arrow EPIDURAL CATHETERIZATION KIT JH-05500Product lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1248-2020 Class II | Arrow EPIDURAL CATHETERIZATION KIT AM-05500Product lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1249-2020 Class II | Arrow EPIDURAL CATHETERIZATION KIT CK-02220Product lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1250-2020 Class II | Arrow SPINAL ANESTHESIA SET ASA-25090-SProduct lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1251-2020 Class II | Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000Product lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1252-2020 Class II | Arrow EPIDURAL NEEDLE KIT SL-05500Product lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1253-2020 Class II | (1) Arrow STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow STIM CPNB TUOHY…Product lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1254-2020 Class II | PICC Set- PR-35052-HPHNMProduct lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |
| Z-1255-2020 Class II | Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSBProduct lidstock contains the incorrect expiration date for the product | 12/20/2019Terminated |