DeRoyal Industries Inc: Medical Device Recalls in 2015

According to to data from the FDA, there were 6 medical device recalls made by DeRoyal Industries Inc in 2015. See the details of the recalls below.

You can see similar recalls for other firms.

• Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-3479-1; LAPAROSCOPY TRAY, REF 89-3605; KNEE/ARTHROSCOPY TRAY, REF 89-3606; SHOULDER/ARTHROSCOPY TRAY, REF 89-3607; LOWER EXTREMITY TRAY, REF 89-3609; BASIC TRAY, REF 89-3610; HAND TRAY, REF 89-3611; NEURO SPINE TRAY, REF 89-3808; NEURO CRANIOTOMY TRAY, REF 89-3809; BASIC SET UP TRAY, REF 89-4137; BASIC PACK, REF 89-4798; SJCHS EXTREMITY TRAY, REF 89-4832; TOTAL KNEE TRAY PGYBK, REF 89-4902; ORTHO SPINE TRAY, REF 89-4935; MAJOR EXTREMITY PACK, REF 89-5057; STANDARD LAP CHOLE PACK, REF 89-5059; UROLOGY CYSTO PACK, REF 89-5246; LAPAROSCOPIC CHOLE PACK, REF 89-5259; FACELIFT & EYELID PACK, REF 89-5609; FACELIFT PACK, REF 89-5611; LAPAROSCOPY PACK, REF 89-5978; HYSTEREOSCOPY TRAY, REF 89-5979; CABG PACK PGYBK A & B, REF 89-5985; OPHTHALMOLOGY PACK PGYBK, REF 89-6263; VASCULAR DRAPE PACK, REF 89-6264; HEART PACK PGYBK, REF 89-6341; SHOULDER PACK, REF 89-6354; MINOR CUSTOM PACK, REF 89-6374; CATARACT PACK PGYBK, REF 89-6377; SURGI-START KIT, REF 89-6378; PACEMAKER PACK, REF 89-6396; GENERAL LAPAROSCOPIC PACK, REF 89-6409; OPEN HEART PROCEDURE PACK TOTAL, REF 89-6508; TOTAL HIP PACK A&B, REF 89-6798; KNEE PACK A&B, REF 89-6799; MAIN OH SUPPLY A&B PACK, REF 89-6855; CRANIOTOMY PACK, REF 89-7017; PACEMAKER PACK, REF 89-7018; GYN MINOR PACK, REF 89-7020; ENT MAJOR PACK, REF 89-7022; GENERAL MAJOR PACK, REF 89-7025; GENERAL MINOR PACK, REF 89-7026; PV PACK, REF 89-7028; GENERAL LAPAROSCOPY PACK, REF 89-7031; CRANIOTOMY PACK, REF 89-7058; LAPAROSCOPY PACK-LF, REF 89-7061; HEAD & NECK PACK, REF 89-7062; VAGINAL HYSTERECTOMY PACK-LF, REF 89-7067; C-SECTION PACK-LF, REF 89-7068; GYN LAPAROSCOPY PACK, REF 89-7075; OPEN HEART PACK, REF 89-7076; C-SECTION PACK, REF 89-7105; TOTAL KNEE PACK, REF 89-7114; ARTHROSCOPY ALL PACK, REF 89-7115; GENERIC ORTHO PACK, REF 89-7116; MINOR EENT PACK, REF 89-7118; COMPANION PACK, REF 89-7189; ENDO VASCULAR PACK, REF 89-7191; OPEN HEART BASIC PACK, REF 89-7281; CUSTOM ER HAND PACK, REF 89-7301; C-SECTION PACK, REF 89-7343; MINOR PACK-LF, REF 89-7390; EXTREMITY PACK, REF 89-7391; ANGIOGRAPHY PACK, REF 89-7398; ANGIOGRAPHY DRAPE PACK PEDI, REF 89-7401; C-SECTION PACK, REF 89-7550; LAMINECTOMY PACK, REF 89-7602; LAPAROSCOPY GEN/UROLOGY PACK, REF 89-7620; LAP CHOLE / APPY TRAY, REF 89-7736; BREAST/TUMMY PACK, REF 89-7737; BASIC PACK, REF 89-7918; LAP CHOLE PACK, REF 89-7924; ROBOTIC SUPPLY URO PACK, REF 89-7990; ROBOTIC SUPPLY GYN PACK, REF 89-7991; SET UP PACK, REF 89-8004; TRAUMA PACK, REF 89-8010; PACEMAKER PACK, REF 89-8191; E HAND PACK, REF 89-8198; NEUROSURGERY PACK, REF 89-8249; SURGERY PACK, REF 89-8261; EYE PACK, REF 89-8273; KNEE PACK, REF 89-8308; SHOULDER PACK, REF 89-8309; HAND PACK, REF 89-8310; PERI/GYN PACK, REF 89-8311; NEURO PACK, REF 89-8372; PODIATRY PACK, REF 89-8379; C-SECTION PACK, REF 89-8394; GENERAL SURGERY PACK, REF 89-8407; GENERAL MALE PACK, REF 89-8409; HAND PACK, REF 89-8416; TOTAL HIP PACK PGYBK, REF 89-8444; TOTAL KNEE PACK PGYBK, REF 89-8445; SURGICAL PODIATRY PACK, REF 89-8464; CATH LAB PACEMAKER PACK, REF 89-8465; BREAST PACK, REF 89-8489; HEAD/NECK PACK, REF 89-8499; EXTREMITY PACK, REF 89-8505; KNEE ARTHROSCOPY PACK, REF 89-8547; SHOULDER ARTHROSCOPY PACK, REF 89-8548; UROLOGY PACK, REF 89-8549; ENT PACK, REF 89-8550; LAMINECTOMY PACK, REF 89-8568; ANT CERV FUSION PACK, REF 89-8652; ENDO BROW FACELIFT PACK, REF 89-8660; PODIATRY PACK, REF 89-8664; GENERAL SURGERY PACK REF 89-8666; Basic Set Up Pack, REF 89-8673; C-SECTION TRAY PGYBK, REF 94-0245; UNIVERSAL BREAST TRAY, REF 94-0266; DR. HAND TRAY, REF 94-0277; FEM-POP TRAY, REF 94-0280 Usage: general surgical
• DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02 GEO-MED sterile custom surgical kits: 1) Open Heart Pack Pgybk, ref 89-5792.10 2) Open Heart A&B Pgybk, ref 89-7626.02 3) Open Heart A&B Pgybk, ref 89-7626.03 4) Open Heat Pack A&B Pgybk, ref 89-8440.01 5) Open Heart Pack A&B Pgybk, ref 89-8440.02
• HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
• DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.
• DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01; TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09; PACEMAKER PACK, REF 89-8381.01;
• DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: TOTAL JOINT PACK A&B, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03