Device recall enforcement reports

Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules

Medical Action Industries, Inc. 306 · Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.

Class IOngoingZ-3106-2026
Status
Ongoing
City
Arden
State
NC
Country
United States
Classification
Class I
Product type
Devices
Event ID
99613
Recalling firm
Medical Action Industries, Inc. 306
Address 1
25 Heywood Rd
Postal code
28704-9302
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Distribution pattern
US distribution to states of: IA, VA, MO, KS, FL, OH and LS.
Recall number
Z-3106-2026
Product description
Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
Product quantity
1,960
Reason for recall
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Recall initiation date
20260723
Center classification date
20260909
Report date
20260916
Code info

UDI-DI: 10809160367414. Lot(Expiration Date): 322200(4/1/2026), 324586(4/1/2026), 327335(4/1/2026), 329618(9/1/2026), 347199(11/1/2026), 337283(11/1/2026), 350354(11/30/2026), 375449(5/31/2027)

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.