Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported September 16, 2020
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
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 or interruption of infusi…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
CareFusion 303, Inc. recalled BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replaceme… - a critical-severity action.
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replaceme… was recalled by CareFusion 303, Inc. in September 16, 2020. Reason: Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially r…. Check the official notice for the remedy. Verify recall #Z-2939-2020 with the FDA Devices before acting.
The recall
CareFusion 303, Inc. issued this critical-severity FDA Devices recall-Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially r….
- Critical
- severity level
- 249K units
- affected scope
- Class I
- classification
- September 16, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2939-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2939-2020) was formally reported on September 16, 2020, with the manufacturer initiating the action on August 4, 2020. It is classified under Critical severity (Class I), with a current status of Ongoing. CareFusion 303, Inc. is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 248,519, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: 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 or interruption of infusion. Delays in an infusion or interruptio… Distribution data in the federal record shows the product reached: Worldwide: US* (AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
248,519
Related Recalls
6
3 from same agency
Product description
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
Reason for recall
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 or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-2939-2020 |
| Date reported | September 16, 2020 |
| Date initiated | August 4, 2020 |
| Recalling firm | CareFusion 303, Inc. |
| Firm location | San Diego, CA |
| Affected scope | 248,519 |
| Distribution | Worldwide: US* (AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY); … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2939-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.. Recalled by CareFusion 303, Inc.. Units affected: 248,519.
Why was this product recalled? ▼
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 or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 16, 2020. Severity: Critical. Recall number: Z-2939-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide: US* (AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY); United Arab Emirates (AE); Australia (AU); Canada (CA); Hungary (HU); Israel (IL); Japan (JP)* Kuwait (KW); New Zealand (NZ); Philippines (PH); Qatar (QA); Saudi Arabia (SA); Singapore (SG); Taiwan (TW); Turkey (TR)*. *There are 159 U.S. government and/or military consignees including two located in Japan (JP) and Turkey (TR)..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2939-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 16, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.