DeRoyal Industries Inc recalls DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the…
Read the official notice →- Date
- 2023-01-18
- Country
- United States
- Brand
- DeRoyal Industries
- Product
- DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
- Classification
- Class II
- Units
- US Nationwide distribution in the states of IL, MO.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 DeRoyal Industries recalls
- 2023-07-12
US
DeRoyal Industries Inc recalls Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB…
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- 2023-06-14
US
DeRoyal Industries Inc recalls Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05,…
The custom procedure packs contain light handle covers that have been recalled by another firm.
- 2023-03-29
US
DeRoyal Industries Inc recalls DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.
FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the states of Arizona, Texas, Virginia,…Official notice →- 2023-01-11
US
DeRoyal Industries Inc recalls DeRoyal Tonsillectomy Tray, REF 89-10698.01
DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may…
- 2022-12-21
US
DeRoyal Industries Inc recalls DeRoyal MYELOGRAM PACK, REF 89-9304.05
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FDA · DeviceDeRoyal Industries IncUS: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts,…Official notice →US
DeRoyal Industries Inc recalls DeRoyal CATARACT PACK CSM, REF 89-6863
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
FDA · DeviceDeRoyal Industries IncUS: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts,…Official notice →
Other drugs & medical recalls in the United States
- 2023-01-18
US
Stradis Healthcare recalls McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
FDA · DeviceStradis HealthcareUS Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN,…Official notice →US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item…
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,…Official notice →US
CareFusion 303, Inc. recalls BD Pyxis MedBank System - Product Label/labeling pending
Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result…
FDA · DeviceCareFusion 303, Inc.U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO,…Official notice →US
International Medical Industries, Inc. recalls Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile;…
Blister package had an unsealed edge compromising sterility.
FDA · DeviceInternational Medical Industries, Inc.US Nationwide Distribution was made to AR, AZ, CA, CO, FL, GA, ID, IL, IN, IA,…Official notice →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…
FDA · DeviceThe Anspach Effort, Inc.US Nationwide and OUS Foreign: Impacted Foreign Countries Australia Bangladesh…Official notice →US
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"