Food, drugs, devices › Avid Medical, Inc.
Device recall: AVID Medical QA Pack AV10654-10
Avid Medical, Inc. (Toano, VA) initiated this device recall on 3 Jul 2017; FDA lists 1 product record under event 79135, classified Class II.
FDA defines Class II as 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 17 Apr 2018. Initiation: voluntary: firm initiated. Avid Medical, Inc. has 24 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Avid Medical, Inc., Toano, VA.
Reason for recall
"The swab stick collection device provided in a convenience kit expires prior to the kit expiration date."
Distribution
"Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0581-2018 | AVID Medical QA Pack AV10654-10 | 330 | Class II | Terminated | 21 Feb 2018 |
Context
Other enforcement events for Avid Medical, Inc.
All 24 events for Avid Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The swab stick collection device provided in a convenience kit expires prior to the kit expiration date."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Apr 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.