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U.S. Department of Health and Human Services

Class 2 Device Recall Sapphire Primary 1.2 Micron Filter Set Microbore Plum Microbore Infusion Sets with inline Filter

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  Class 2 Device Recall Sapphire Primary 1.2 Micron Filter Set Microbore Plum Microbore Infusion Sets with inline Filter see related information
Date Initiated by Firm July 29, 2019
Create Date October 14, 2019
Recall Status1 Terminated 3 on January 12, 2024
Recall Number Z-0127-2020
Recall Event ID 83549
510(K)Number K141789  
Product Classification Accessories, pump, infusion - Product Code MRZ
Product Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50 pouches per case



Code Information Product Code: 142560488, Lot number (UDI Number): 865455H (20887787005237, 10887787005230), 896215H (20887787005237, 10887787005230), 897455H (20887787005237, 10887787005230), 3864785 (20887787005237, 10887787005230), 4095291 (20887787005237, 10887787005230);
Recalling Firm/
Manufacturer		 ICU Medical Inc
600 N Field Dr
Lake Forest IL 60045-4835
For Additional Information Contact
866-829-9025
Manufacturer Reason
for Recall		 Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
FDA Determined
Cause 2		 Under Investigation by firm
Action ICU Medical notified customers, via Stericycle, Inc., on about 07/29/2019 via "URGENT: MEDICAL DEVICE CORRECTION" letter. Customers were instructed to check inventory and quarantine any sets that are affected by the recall, return them to ICU Medical, inform potential users within your organization of the recall, and complete and return the provided response form. Please notify customers if affected product was further distributed and request that they contact Stericycle at 1-855-311-5437 (M-F, 8am-5pm ET) to receive a reply form. Customers were also requested to consider the following situations: 1. In applications where the use of a filter is not deemed necessary, consider utilizing an administration set without a filter. 2. In applications where filter use is desired and microbore tubing is not required, consider using filtered macrobore sets in place of microbore sets. 3. In cases where a filtered macrobore set is desired but no alternative macrobore set is available contact ICU Medical because a non-filtered set along with an add on filter or filtered extension set could be considered. 4. In instances where the benefits of a filtered microbore infusion set are greater than the potential risks of a filter leak, the product affected by the recall may be utilized out of medical necessity. In these cases, an individualized assessment of benefits and risks should be undertaken with consideration of the unique characteristics of the patient and the infusion itself. When the benefits exceed the risks and the set is deemed medically necessary, users should periodically monitor the vented filter area for leakage. If leaking is observed, consider changing to a new infusion set as soon as clinically appropriate. Report this event to ICU Medical.
Quantity in Commerce 78,877 units
Distribution Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MRZ and Original Applicant = HOSPIRA, INC.
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