Integra LifeSciences Corp. recalls Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.
Read the official notice →- Date
- 2023-01-18
- Country
- United States
- Brand
- Integra LifeSciences
- Product
- Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of CA, CO,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Integra LifeSciences recalls
- 2023-12-13
USIntegra LifeSciences Corp. recalls Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →- US
Integra LifeSciences Corp. recalls Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of…
Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2023-05-31
- US
Integra LifeSciences Corp. recalls Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device…
Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay,…
- 2022-08-03
- US
Integra LifeSciences Corp. recalls CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by…
FDA · DeviceIntegra LifeSciences Corp.Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong…Official notice → - 2022-04-20
- US
Integra LifeSciences Corp. recalls Integra Universal Flexible Arm part number REF 1362275
Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.
FDA · DeviceIntegra LifeSciences Corp.US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TXOfficial notice → - 2022-03-30
- US
Integra LifeSciences Corp. recalls Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device…
Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the country of Hong Kong.Official notice →
Other drugs & medical recalls in the United States
- 2023-01-18
- US
The Anspach Effort, Inc. recalls Pediatric Craniotome Ref:CRANI-P-G1
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection…
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Medtronic Neuromodulation recalls Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
- US
Bayer Medical Care, Inc. recalls Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material…
Black specks may be present on the packaged needles
FDA · DeviceBayer Medical Care, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, IN,…Official notice → - US
Philips North America Llc recalls Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Ventana Medical Systems, Inc. recalls VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive)…
Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent…
FDA · DeviceVentana Medical Systems, Inc.Worldwide distribution - U.S. Nationwide distribution including in the states…Official notice → - US
Philips Respironics, Inc. recalls Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B,…
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially…
FDA · DevicePhilips Respironics, Inc.US Nationwide and Global Distribution to countries of: Australia, Brazil,…Official notice →