| | Class 2 Device Recall Arrow ThreeLumen CVC |  |
| Date Initiated by Firm | May 05, 2022 |
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| Date Posted | June 27, 2022 |
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| Recall Status1 |
Terminated 3 on September 04, 2024 |
| Recall Number | Z-1290-2022 |
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| Recall Event ID |
90147 |
| 510(K)Number | K970864 |
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| Product Classification |
Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
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| Product | Arrow Three-Lumen CVC |
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| Code Information |
Catalog Number: CV-12123-F; Lot Numbers: 71F20A0430 [UDI: (01)20801902122838(17)211214(10)71F20A0430], 71F20A2583 [UDI: (01)20801902122838(17)250103(10)71F20A2583], 71F20B0793 [UDI: (01)20801902122838(17)250115(10)71F20B0793], 71F20B2188 [UDI: (01)20801902122838(17)250204(10)71F20B2188], 71F20C1356 [UDI: (01)10801902136944(17)220630(10)71F20C1356], 71F20D1047 [UDI: (01)20801902122838(17)250402(10)71F20D1047], 71F20E2225 [UDI: (01)20801902122838(17)250531(10)71F20E2225], 71F20G2376 [UDI: (01)20801902122838(17)250701(10)71F20G2376], 71F20K0771 [UDI: (01)20801902122838(17)241130(10)71F20K0771], 71F20K2265 [UDI: (01)20801902122838(17)250228(10)71F20K2265], 71F20L0567 [UDI: (01)20801902122838(17)250228(10)71F20L0567], 71F20M1262 [UDI: (01)20801902122838(17)250331(10)71F20M1262], 71F21B0849 [UDI: (01)10801902179514(17)250430(10)71F21B0849], 71F21B0850 [UDI: (01)20801902122838(17)250430(10)71F21B0850], 71F21B2430 [UDI: (01)20801902122838(17)250430(10)71F21B2430], 71F21C0637 [UDI: (01)20801902122838(17)250331(10)71F21C0637], 71F21C0964 [UDI: (01)10801902170856(17)260214(10)71F21C0964], 71F21D0025 [UDI: (01)20801902122838(17)250430(10)71F21D0025], 71F21E0586 [UDI: (01)20801902122838(17)250430(10)71F21E0586], 71F21E1030 [UDI: (01)20801902122838(17)250430(10)71F21E1030], 71F21E2583 [UDI: (01)20801902122838(17)250430(10)71F21E2583], 71F21F1156 [UDI: (01)20801902122838(17)250430(10)71F21F1156], 71F21J0698 [UDI: (01)20801902122838(17)250430(10)71F21J0698] |
Recalling Firm/
Manufacturer |
ARROW INTERNATIONAL Inc.
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
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| For Additional Information Contact |
866-396-2111 |
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Manufacturer Reason
for Recall | Gravity flow rates on the affected product lidstock are incorrect. |
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FDA Determined
Cause 2 | Error in labeling |
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| Action | A recall notification was issued to the consignee on 05/05/2022 via FedEx 2-day mail. The letter instructs the consignee to check the inventory, place a copy of the letter with all affected product and return the response form if the consignee is a medical facility. If the consignee is a distributor, the letter instructs the consignee to provide the notice to their customers, check the inventory, return the completed response form.
An updated notification was sent on about 08/09/2022, via FedEx. The updated notification provided an additional description of the label error. Product scope remains the same. |
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| Quantity in Commerce | 10,301 units |
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| Distribution | US Nationwide distribution in the states of Florida. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = FOZ
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