PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Check against the official notice below — it lists the full affected range.
B Braun Medical Inc is recalling 6 units of the PERFUSOR SPACE syringe infusion pump (Catalog Number 8713030U) distributed in Massachusetts and Vermont. The units were not properly inspected before being released to the market and may not function as described in the product labeling, which could affect how the pump detects syringes and delivers medication.
The potential issues with these units include delays in therapy, overinfusion (delivering too much medication), or underinfusion (delivering too little medication). The affected units have serial numbers 633299, 633307, 633310, 633313, 633315, and 633318. The recall source does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
Reason for recall: Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion. Distribution: US Distribution to states of: MA, VT Quantity: 6 units Lot/code info: Serial Numbers: 633299, 633307, 633310, 633313, 633315, 633318 GUIDID: 04046963716745
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.