CLASS II Device recall · Reported 26 Jan 2022 · FDA Enforcement Report
Kwik-stik 2 Pack, Catalog #0894P; Kwik-stik 6 Pack, Catalog #0894K recalled
Microbiologics is recalling Kwik-stik 2 Pack, Catalog #0894P; Kwik-stik 6 Pack, Catalog #0894K, distributed in 13 states. The recall was initiated on 16 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0511-2022
- FDA event ID
- 89285
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Dec 2020
- FDA classified
- 19 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Dec 2020 | Recall initiated by company | |
| 19 Jan 2022 | Classified by FDA | +399 days |
| 26 Jan 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Contamination with S. epidermidis
Product as listed by the FDA
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
Where it was distributed
Distribution was made to CA, IA, IL, LA, MA, MI, NY, PA, SD, TN, VA, WI, and WV. There was no government/military distribution. Foreign distribution was made to Brazil, Canada, Colombia, Dominican Republic, Finland, France, India, Japan, Malaysia, Mexico, Netherlands, Poland, Romania, Saudi Arabia, Serbia, South Africa, and United Kingdom.
CaliforniaIowaIllinoisLouisianaMassachusettsMichiganNew YorkPennsylvaniaSouth DakotaTennesseeVirginiaWisconsinWest Virginia
Questions about this recall
Is Kwik-stik 2 Pack, Catalog #0894P; Kwik-stik 6 Pack, Catalog #0894K recalled?
Yes. Microbiologics recalled Kwik-stik 2 Pack, Catalog #0894P; Kwik-stik 6 Pack, Catalog #0894K on 16 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-0511-2022.
Why was it recalled?
Contamination with S. epidermidis
Which lots are affected?
KWIK-STIK 2 Pack - Catalog#: 0894P, Lot #: 894-68-3, Exp. 6/30/2022, 894-68-4, Exp. 6/30/2022, UDI: 20845357022947; KWIK-STIK 6 Pack - Catalog#: 0894K, Lot #: 894-68-1, Exp. 6/30/2022, UDI: 30845357022951; LYFO DISK - Catalog#: 0894L, Lot #: 894-68-2, Exp. 6/30/2022, UDI: 10845357022964;
Where was it sold?
Distribution was made to CA, IA, IL, LA, MA, MI, NY, PA, SD, TN, VA, WI, and WV. There was no government/military distribution. Foreign distribution was made to Brazil, Canada, Colombia, Dominican Republic, Finland, France, India, Japan, Malaysia, Mexico, Netherlands, Poland, Romania, Saudi Arabia, Serbia, South Africa, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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