Catalog Number: AEBD35 Batch Number: Lot Coloplast 3805926/supplier lots 91303666 and 91303667 - manufacturing date 09-2013, expiry date 08-2018 Lot Coloplast 4413375/supplier lot 91405680 - manufacturing date 11-2014, expiry date 10-2019 Lot Coloplast 4413376/supplier lot 91500532 - manufacturing date 02-2015, expiry date 01-2020/supplier lot 91405681- manufacturing date 04-2015, expiry date 03-2020. Lot Coloplast 4614015/supplier lots 91502257 and 91502429 manufacturing date 04-2015, expiry date 03-2020
Nationwide Distribution including Puerto Rico and the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS,MO,NE,NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WV.
Descripción del producto
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. || Urine Collection Bag.
Nationwide Distribution including AL, AZ, CA, CO, CT, DE, FL,GA, ID, IL, IA, MD, MA, MI, MN, MS, NJ, NY, NC, OH, OK, OR, PA,PR, SC, TN, TX VA, WA, WI.
Descripción del producto
SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Coloplast -A/S 3050 Denmark. || 28022S 1400 SureCath Set,acc CH8 Male,bulk || 28023S 1400 Surecath Set,acc CH10 Male,bul || 28024S 1400 Surecath Set,acc CH12 Male,bul || 280320 1400 SureCath Set,acc CH14 Male || 28032S 1400 Surecath Set,acc CH14 Male,bul || 28036S 1400 Surecath Set,acc CH14/1,2 Male || 28037S 1400 Surecath Set,acc CH16 Male || 280370 1400 Surecath Set,acc CH16 Male || 28033S 1400 Surecath Set,acc CH16 Male || 280360 1400 Surecath Set,acc CH14/1,2 Male || 280340 1400 SURECATH SET W.ACC FEM14` || The SureCath Set is indicated for use by patients for intermittent catherization for the purpose of bladder drainage. The insertion supplies provided are to be used to insert the catheter using sterile technique.
Nationwide Distribution including AL, AZ, CA, CO, CT, DE, FL,GA, ID, IL, IA, MD, MA, MI, MN, MS, NJ, NY, NC, OH, OK, OR, PA,PR, SC, TN, TX VA, WA, WI.
Descripción del producto
SpeediCath , SpeediCath with Accessories || Coloplast Corp -MN, Sterile R, Manufacturer Coloplast -A/S 3050 Denmark || 284821 1400 SpeediCath, acc CH10 Male || 284831 1400 SpeediCath, acc CH12 Male || 284841 1400 SpeediCath, acc CH14 Male || 284851 1400 SpeediCath, acc CH16 Male || 284861 1400 SpeediCath, acc CH18 Male || 284811 1400 SpeediCath, acc CH8 Male || 285011 1400 SpeediCath,acc CH10 Female || 285021 1400 SpeediCath,acc CH12 Female || 285031 1400 SpeediCath,acc CH14 Female || 285041 1400 SpeediCath,acc CH16 Female || 284991 1400 SpeediCath,acc CH6 Female || 285001 1400 SpeediCath,acc CH8 Female || The SpeediCath catheter is indicated for use by patients with chronic urine retention and patients with post void a residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urin to drain. The insertion supplies provided are to be used to insert the catheter using sterile technique.
Nationwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, GA, LA, MA, MD, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, RI, TN, TX, VA, WA, and WI.
Descripción del producto
Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with window, 100 mm , Sterilized using ethylene oxide; SenSura 19010 Post-Op ,ostomy bag with window, 70 mm , Sterilized using ethylene oxide; SenSura 19001 Drainable bag with soft tap 1 piece/Opaque with inspection windows, 10-76 mm Sterilized using ethylene oxide, Manufacturer: Colopast A/S 3050 Denmark.) || Coloplast Corp.-MN 06093, Country of origin: HU , No. 128100 1400 (Assura Post-Op 12810 pouches with window single use only, Sterile EO, 1/2" -3 7/8"/13-100mm) ; No. 128 180 1400 (Assura 12818 Post-Op, pouches without window, single use, Sterile EO, 1/2" -2 3/4"/13-70mm , Cut-to fit.; No. 128080 1400 ( Assura Post Op, 12808, pouches with window, single use, Sterile EO, 2 3/4 / 70 mm , Cut- to- fit) , Manufacturer: Colopast A/S 3050 Denmark. || These products are typically the first pouches applied in the OR following ostomy surgery. The one-piece drainable minimizes pressure on the abdomen, the soft drainable outlet accommodates the post-operative liquid output, and the inspection window allows a nurse to inspect and / or tend to the new stoma or wound. Thereafter, non-sterile bags are used for ostomy management both prior to and after the patient is discharged from the hospital.
Peristeen Anal Irrigation System manufactured by Coloplast Limited.
The following Peristeen product codes contain rectal catheters:
29121 – Peristeen Anal Irrigation System (contains two rectal catheters)
29122 – Accessory Unit (contains 15 rectal catheters and one bag)
29123 – 10 rectal catheters
29126 – Peristeen Anal Irrigation System (contains two rectal catheters - small)
29127 – Accessory Unit (contains 15 rectal catheters – small and one bag)
29128 – 10 rectal catheters – small
Peristeen anal irrigation system manufactured by Coloplast Limited.
The instructions for use have been updated in response to publication of the review article ’Concensus review of best practice of transanal irrigation in adults’.
Consensus review of best practice of transanal irrigation in adults
(external link)
All batches of the following devices manufactured by Coloplast A/S are affected:Testicular implants, product codes: PR3001, PR3002, PR3003, PR3004, PR3005Vaginal stents – inflatable, product codes: VS3020, VS3022, VS3024, VS3026