CLASS I ONGOING Device recall · Reported 16 Sep 2020 · FDA Enforcement Report
PC Unit Front Case with Keypad Replacement Kits recalled
CareFusion 303 is recalling PC Unit Front Case with Keypad Replacement Kits: TC10008389 Assy Case Front W/Keypad, distributed in 50 states. The recall was initiated on 4 Aug 2020 and the FDA has classified it as Class I.
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-2910-2020
- FDA event ID
- 85900
- Recalling firm
- CareFusion 303, San Diego, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 4 Aug 2020
- FDA classified
- 4 Sep 2020
- Reported
- 16 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Aug 2020 | Recall initiated by company | |
| 4 Sep 2020 | Classified by FDA | +31 days |
| 16 Sep 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.
Product as listed by the FDA
PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS, TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2
Where it was distributed
U.S.:LA, FL, KY, MI, AL, GA, CA, TN, NC, TX, MA, OH, CO, WI, IL, KS, MO, UT, AK, MD, NY, NV, VA, NE, IN, PA, VT, DC, SC, CT, AR, NJ, MT, ND ,HI , NH, WA, DE, ME, OR, MN, AZ, MS, IA, NM, WY, ID, OK, SD, WV, MP, GU O.U.S.: CA, AE, AU, BE, CA, CH, IL, IN, KW, N/A, NL, NZ, PH, QA, SA, SG, TW, US, ZA
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is PC Unit Front Case with Keypad Replacement Kits: TC10008389 Assy Case Front W/Keypad recalled?
Yes. CareFusion 303 recalled PC Unit Front Case with Keypad Replacement Kits: TC10008389 Assy Case Front W/Keypad on 4 Aug 2020. The recall is Class I and its status is Ongoing. Recall number Z-2910-2020.
Why was it recalled?
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.
Which lots are affected?
All kits manufactured from April 07, 2017 to Present.
Where was it sold?
U.S.:LA, FL, KY, MI, AL, GA, CA, TN, NC, TX, MA, OH, CO, WI, IL, KS, MO, UT, AK, MD, NY, NV, VA, NE, IN, PA, VT, DC, SC, CT, AR, NJ, MT, ND ,HI , NH, WA, DE, ME, OR, MN, AZ, MS, IA, NM, WY, ID, OK, SD, WV, MP, GU O.U.S.: CA, AE, AU, BE, CA, CH, IL, IN, KW, N/A, NL, NZ, PH, QA, SA, SG, TW, US, ZA
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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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