Baxter Healthcare Corporation recalls Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Product was distributed in the United States without proper regulatory approval.
Read the official notice →- Date
- 2024-05-01
- Country
- United States
- Brand
- Baxter Healthcare
- Product
- Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
- Classification
- Class II
- Units
- US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Baxter Healthcare recalls
- 2024-06-26
US
Baxter Healthcare Corporation recalls Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent…
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
FDA · DeviceBaxter Healthcare CorporationDistribution was made nationwide. There was also government/military…Official notice →- 2024-05-22
US
Baxter Healthcare Corporation recalls Spectrum IQ Infusion pump, Product Code 357009
There is a potential for cracks on the mount of the front panel of the device.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of Ohio, Wisconsin.Official notice →- 2024-05-15
US
Baxter Healthcare Corporation recalls Baxter Spectrum IQ Infusion Pump, Product Code 3570009
One device was improperly performed testing prior to release from a Service Center.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of Massachusetts.Official notice →- 2024-04-24
US
Baxter Healthcare Corporation recalls Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021,…
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Canada, Ireland,…Official notice →- 2024-04-17
US
Baxter Healthcare Corporation recalls Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP,…
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
- 2024-04-10
US
Baxter Healthcare Corporation recalls Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or…
Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your devices have been identified as…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of Colorado.Official notice →
Other drugs & medical recalls in the United States
- 2024-05-08
US
US
- 2024-05-01
US
Philips North America Llc recalls Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V…
Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power. may lead to…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Argentina, Aruba,…Official notice →US
Electro Medical Systems SA recalls Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These…
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the…
FDA · DeviceElectro Medical Systems SAWorldwide distribution - U.S. Nationwide in the states of IL and TX. The…Official notice →US
Quidel Corporation recalls QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may…
FDA · DeviceQuidel CorporationUS: AK AL AR AZ CA CO CT DC FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MT NC…Official notice →US
Covidien LP recalls Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and…
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
FDA · DeviceCovidien LPWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice →