Recall Weekly
Serious riskFDA DeviceClass I

Arrow spinal anesthesia kits recalled for possible sterility loss

Arrow International included injectable medications (lidocaine, bupivacaine, and sodium chloride) from a supplier with quality issues in multiple spinal anesthesia kits. The supplier's products may not be sterile or effective, which could cause serious injury during spinal procedures.

From the FDA notice · Read the official notice ↗

What to do

  1. Check your facility's inventory against the affected lot numbers listed in the FDA notice
  2. Do not use affected kits; quarantine them immediately
  3. Contact Arrow International or your supplier for instructions on returning or replacing affected kits
  4. Verify any spinal anesthesia kits used recently came from unaffected lots
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINAL ANESTHESIA KIT: 25 GA X 9 CM/ASK-24090-SPH; SPINAL ANESTHESIA KIT/ASK-25090-BIDMC; SPINAL ANESTHESIA KIT/ASK-25090-UF
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 35 products — see all of them.

Details

Units affected
79,614
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2389-2026

In the FDA's words

Description
Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINAL ANESTHESIA KIT: 25 GA X 9 CM/ASK-24090-SPH; SPINAL ANESTHESIA KIT/ASK-25090-BIDMC; SPINAL ANESTHESIA KIT/ASK-25090-UF Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. REF(Material)/UDI-DI/Lot(Batch): ASA-24090-SB/10801902193275, 10801902201994/33F24G0383, 33F24K0145, 33F24L0550, 33F25A0491, 33F25C0838, 33F25E0094, 33F25H0044, 33F25J0490, 33F25L0444, 33S25E0094; ASA-24103-SB/10801902202007, 10801902193275/33F24E0380, 33F24E0381, 33F24G0274, 33F24K0146, 33F24L0696, 33F25A0492, 33F25C0123, 33F25C0774, 33F25E0095, 33F25G0097, 33F25H0045, 33F25J0491, 33F25L0329, 33F26B0494; ASA-25090-SB/10801902202014, 10801902193275/33F24E0089, 33F24E0090, 33F24G0384, 33F24K0147, 33F24L0545, 33F24L0755, 33F25A0493, 33F25A0621, 33F25B0374, 33F25C0844, 33F25E0097, 33F25G0098, 33F25H0046, 33F25J0850, 33F25K0257; ASK-24090-SA/10801902202281, 10801902193275/33F24D0396, 33F24E0544, 33F24L0589, 33F25C0182, 33F25C0965, 33F25E0228, 33F25H0146, 33F25J0922, 33F26B0573; ASK-24090-SPH/10801902202274, 10801902193275/33F24D0397, 33F24G0505, 33F24K0260, 33F24L0654, 33F25A0575, 33F25C0943, 33F25E1026, 33F25H0753, 33F25K0410, 33F26B0501; ASK-25090-BIDMC/10801902210217/33F24E0546, 33F24E0547, 33F24L0636, 33F25C0183, 33F25C0831, 33F25E0230, 33F25J0923, 33F25L0357; ASK-25090-UF/10801902206692, 10801902193275/33F24E0548, 33F24L0602, 33F25C0806, 33F25E0231, 33F25G0138, 33F25J0557, 33F25M0957; Distribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR. Affected quantity: 79,614
Hazard
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

35 products in this recall

Arrow kits with lidocaine and bupivacaine recalled for sterility risk

Arrow is recalling 35 kits and sets that contain lidocaine, bupivacaine, or 0.9% sodium chloride from a supplier that was itself recalled for quality issues. If the sterility of these water-based injectable drugs is compromised, it could lead to serious or life-threatening injuries. No injuries have been reported, and the products were distributed nationwide.

The agency lists each product separately. Check every one you might have.

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