Recall Z-2873-2016
Hospira Inc. · initiated March 8, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.
Codes / lots: Serial Number 15553367, 16224548, 16224939, 16225091, 16225646, 16225851, 16226006, 16226095, 16226117, 16226159, 16226360, 16226383, 16226435, 16226460, 16226680, 16226707, 16226726, 16226730, 16226756, 16226763, 16226891, 16226895, 16226898, 16226910, 16226917, 16226918, 16226919, 16226920, 16226921, 16226922, 16226923, 16226924, 16226925, 16226926, 16226927, 16226928, 16226929, 16226930, 16226931, 16226932, 16226933, 16226934, 16226935, 16226936, 16226937, 16226938, 16226939, 16226940, 16226941, 16226943, 16226944, 16226945, 16226946, 16226947, 16226948, 16226949, 16226950, 16226951, 16226952, 16226953, 16226954, 16226955, 16226956, 16226957, 16226958, 16226959, 16226960, 16226961, 16226962, 16226963, 16226964, 16226965, 16226966, 16226967, 16226968, 16226969, 16226970, 16226971, 16226972, 16226973, 16226974, 16226975, 16226976, 16226977, 16226978, 16226979, 16226980, 16226981, 16226982, 16226983, 16226984, 16226985, 16226986, 16226987, 16226988, 16226989, 16226990, 16226991, 16226992, 16226993, 16226994, 16226995, 16226996, 16226997, 16226998, 16226999, 16227000, 16227001, 16227002, 16227003, 16227004, 16227005, 16227006, 16227007, 16227008, 16227009, 16227010, 16227011…
Reason for recall
Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops.
FDA-determined cause: Nonconforming Material/Component
Action taken
Hospira will contract with Stericycle, Inc. in Indianapolis, IN to send letter and a reply form to Hospira, Inc. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating the number of pumps on hand and that they have received the letter and notified their users. In addition, letters will be sent by email to ECRI, NRAC, Noblis and ISMP for notification of their members and posting on their websites. The letter will also be posted to the Hospira website. Letters will be sent to Hospira customers of record who purchased the devices directly from Hospira. Customers will be directed to notify their consignees if they further distributed the product and confirm they have done so. Telephone attempts will be made to contact customers that do not respond in order to confirm receipt of the letter. Final effectiveness will be done as the devices are upgraded with new plastic motors.
Details
- Recall number
- Z-2873-2016
- Initiated
- March 8, 2013
- Terminated
- November 7, 2016
- Product code
- MEA – Pump, Infusion, Pca
- Quantity
- 8,794
- Distribution
- United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2874-2016 Class II | LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or…Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the… | 03/08/2013Terminated |