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.
FDA Recall Z-2409-2011 · Posted 2011-06-03
Advertisement
Reason for Recall
Firm Action
Root Cause
Incorrect or no expiration date
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement