Recall Z-1566-2023— ICU Medical Inc
Class I · Ongoing
Class I FDA medical device recall by ICU Medical Inc, initiated 2023-03-22. It names 2 FDA 510(k) clearances: K070398, K042081. Product: Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973. Reason: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected..
- Recalling firm
- ICU Medical Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-03-22
- Firm location
- Lake Forest, IL, United States
510(k) clearances named in this recall
2 on FDA's record- K070398 — HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
- K042081 — PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973
Reason for recall
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Data sourced from openFDA. This site is unofficial and independent of the FDA.