Baxter IntelliFill Pharmacy Compounding Device Recalled for Filtration Defect
Baxter Healthcare is recalling 28 IntelliFill i.v. Pharmacy Compounding Devices because they may operate with HEPA filtration disabled.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could lead to the administration of non-sterile medication, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corp. is recalling 28 units of the IntelliFill i.v. Pharmacy Compounding Device (PCD). These devices are intended to fill syringes ranging from 0.5mL to 11.5mL using mixing instructions from their formulary. The affected units were distributed nationwide, including in California, Colorado, Connecticut, Florida, Illinois, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, Nebraska, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, and West Virginia.
The recall was initiated following a retrospective review of a complaint (CR-954) that identified a potential defect in the devices. The IntelliFill PCDs have the potential to continue running and filling syringes while the HEPA filtration system is disabled. This defect could compromise the sterility of the compounded medications.
Healthcare facilities and pharmacies that possess these devices should stop using them immediately. Affected lot numbers include 123, 125R, 127, 129, 145, 146R, 147R, 148, 215R, 500, 501, 502, 503, 504, 505, 506, 508, 510, 511R, 512, 514, 515, 516R, 517, 518, 519, and 520. Users should contact Baxter Healthcare for instructions on how to return the devices.
The recalled product
- Product
- IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 28
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot # 123
- 125R
- 127
- 129
- 145
- 146R
- 147R
- 148
- 215R
- 500
- 501
- 502
- 503
- 504
- 505
- 506
- 508
- 510
- 511R
- 512
Distribution
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