Recall Weekly
Serious riskFDA DeviceClass I

Arrow PI CVC kits recalled for possible sterility compromise

Arrow International included anesthetic and saline components from a supplier with quality issues in several percutaneous central venous catheter (CVC) kits. The supplier's products showed limited reports of drug ineffectiveness, and compromised sterility in injectable products could cause serious injury.

From the FDA notice · Read the official notice ↗

What to do

  1. If you use or have these kits (ASK-42703-PNHS2, ASK-45703-PNHS2, or ASK-45854-PNHS2), stop using them immediately.
  2. Contact your healthcare facility or Arrow International for instructions on returning or disposing of affected kits.
  3. Check lot numbers 33F25J0107, 33F25B0593, and 33F24H0128 against your inventory.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PNHS2
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 35 products — see all of them.

Details

Units affected
0
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2375-2026

In the FDA's words

Description
Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PNHS2 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): ASK-42703-PNHS2/10801902193275/33F25J0107; ASK-45703-PNHS2/10801902193275/33F25B0593; ASK-45854-PNHS2/10801902193275/33F24H0128 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: 0
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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