Recall Weekly
Serious riskFDA DeviceClass I

Arrow Biopsy System kits recalled for possible drug sterility risk

Arrow International included anesthetic medications (lidocaine and bupivacaine) and saline solution from a supplier with quality problems in its biopsy system kits. The supplier had 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. Check if you have any of the affected biopsy kit models (ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, or ASK-09458-VU)
  2. Do not use kits with lot numbers listed in the FDA notice
  3. Contact Arrow International or your healthcare facility for instructions on returning or replacing affected kits
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 35 products — see all of them.

Details

Units affected
14,840
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2365-2026

In the FDA's words

Description
Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU 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-09458-AH/10801902203172, 10801902193275, 10801902203172/33F24C0359, 33F24C1122, 33F24E0323, 33F24F0780, 33F24K0397, 33F25A0208, 33F25B0518, 33F25D0001, 33F25D0338, 33F25D0465, 33F25E0528, 33F25H0610, 33F25J0353, 33F25K0076, 33F25K0091, 33F25M0173, 33F26A1538, 33F26B0819, 33F24H0227; ASK-09458-COC/10801902193275, 10801902221084, 10801902216394/33F24K0755, 33F25C0380, 33F25D0590, 33F25H0583, 33F25J0354, 33F25K0125, 33F25M0243, 33F25M0393, 33F26A1535, 33F26B0404, 33F24F0732; ASK-09458-EUH/10801902193275, 10801902216394/33F24L0908, 33F25E0715, 33F25F0096, 33F25G0215, 33F25J0144, 33F25M0118, 33F26A1515, 33F26B0862, 33F24H0125; ASK-09458-SD/10801902193275, 10801902215014/33F25D0398, 33F25F0165, 33F25M0692, 33F26C0488; ASK-09458-VU/10801902217261, 10801902193275, 10801902217261, 10801902193275/33F24C0832, 33F24D0624, 33F24F0650, 33F24K0752, 33F24L0916, 33F25D0534, 33F25E0531, 33F25F0141, 33F25H0588, 33F25K0127, 33F25M0177, 33F26B0134, 33F26B0477, 33F26C0487, 33F24H0099 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: 14,840
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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