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Recall Observatory FDA recall evidence

Device product

(1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow¿ STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-18080-N (4) Arrow¿ STIM CPNB TUOHY NDL: 17G x 8CM (3-1/8") AB-17080-N (5) Arrow¿ STIM CPNB TUOHY NDL: 17G x 14CM (5-1/2") AB-17140-N (6) Arrow¿ INSL CPNB TUOHY NDL: 17G x 15CM (6") AB-00150 (7) Arrow¿ STIM CPNB TUOHY NDL: 17G x 11CM (4-3/8") AB-17110-N

Z-1253-2020

December 20, 2019

Class II

Product summary

Firm
Arrow International Inc
Event
Event 84688
Status
Terminated
Classification
Class II
Quantity
2126
Official record key
device-enforcement:Z-1253-2020

Official wording

Reason: Product lidstock contains the incorrect expiration date for the product

Code information: Lot Number: (1) AB-00150 13F16B0155; (2) AB-17080-N 13F18J0654, 13F16H0046,13F16F0210, 13F16E0106, 13F16C0107; (3) AB-17110-N 13F16G0226, 13R16G0226, 13F16F0079; (4) AB-17140-N 13F16F0190, 13F16C0045; (5) AB-18080-N 13F16H0048, 13F16F0007, 13F16B0181, (6) AB-18110-N 13F16F0189, 13F16C0046; (7) AB-18140-N 13F16H0292;

Distribution pattern: Nationwide Foreign: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product lidstock contains the incorrect expiration date for the product