Arrow International Recalls Tuohy Needles With Incorrect Expiration Dates
Arrow International Inc is recalling 2,126 units of STIM and INSL CPNB Tuohy needles because the product lidstock contains the incorrect expiration date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a minor labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc is recalling 2,126 units of Arrow STIM and INSL CPNB Tuohy needles. The recall involves multiple sizes and gauge configurations, including 18G and 17G needles with lengths ranging from 8 cm to 15 cm. The specific product codes affected include AB-18140-N, AB-18110-N, AB-18080-N, AB-17080-N, AB-17140-N, AB-00150, and AB-17110-N.
The reason for the recall is that the product lidstock contains the incorrect expiration date for the product. This is a labeling error that may affect the verification of the product's shelf life. The agency has classified this recall as Class II.
The affected products were distributed nationwide and in foreign countries including Austria, Australia, Germany, Canada, Czech Republic, Guatemala, New Zealand, Poland, Slovakia, and South Africa. Specific lot numbers are listed in the recall documentation. Consumers and healthcare providers should check their inventory for these specific product codes and lot numbers. If the products are found, they should be returned to the distributor or the manufacturer for credit or replacement.
The recalled product
- 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…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 2,126
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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