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U.S. Department of Health and Human Services

Class 2 Device Recall Spinning Spiros

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  Class 2 Device Recall Spinning Spiros see related information
Date Initiated by Firm August 31, 2020
Create Date December 23, 2020
Recall Status1 Open3, Classified
Recall Number Z-0699-2021
Recall Event ID 86426
510(K)Number K070532  
Product Classification Set, administration, intravascular - Product Code FPA
Product 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Clamps, Spiros, REF: CH3367; 7" (18 cm) Appx 0.40 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, Spiros, 2 Clamps, REF: CH3379; 16" (41 cm) Appx 4.4 ml, Ext Set w/MicroClave, 0.2 Micron Filter, Clave, Spiros, Clamp, REF: CH3381; 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros w/Drop-in Red Cap, 2 Hanger, REF: CH3386; 40" (102 cm) Appx 7.3 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, REF: CH3401; 60" (152 cm) Appx 0.62 ml, Smallbore Ext Set w/MicroClave, Clamp, Spiros w/Red Cap, REF: CH3405; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Clave, Spiros w/Red Cap, REF: CH3453; 73" (185 cm) Appx 2.1 ml, Smallbore Ext Set w/MicroClave Clear, Spiros, Clamp, REF: CH3485; 42" (107 cm) Appx 4.8 ml, 15 Drop Admin Set w/Spiros w/Red Cap, Bag Hanger, Drop-In Priming Cap, REF: CH3517; 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/MicroClave Clear, 2 Spiros, 3 Clamps, Priming Cap, REF: CH3523; 74" (188 cm) Smallbore Ext Set w/MicroClave, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3533; 74 IN (188 cm) Appx 0.92 ml, Smallbore Set, MicroClave, 1.2 Micron Fil, Spiros, Red Cap, REF: CH3538; 18" (46 cm) Appx 5.1 ml, Ext Set w/0.2 Micron Filter, Clave, Spiros, Clamp, REF: CH3556; 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3603; 4-Way Clave Stopcock w/2 Spiros, REF: B4194; Spiros, Closed Male Connector w/Red Cap (10 Units), REF: Z7093; 47" (119 cm) 150 ml Burette Set w/MicroClave, 20 Drop In-Line Drip Chamber w/Ball Shut Off, Spiros, REF: Z7182




















Code Information Lot:  4764635, 4887770, 4787215, 4877053, 4737148, 4850390, 4749863, 4849350, 4867377, 4741238, 4763286, 4774081, 4809085, 4877072, 4908343, 4719787, 4734320, 4741243, 4749867, 4854763, 4895575, 4849358, 4751063, 4763289, 4775529, 4724813, 4749880, 4854774, 4734335, 4757706, 4849376, 4764061, 4793547, 4749900, 4756873, 4777159, 4799805, 4902253, 4751908, 4793550, 4849389, 4896178, 4733498, 4764065, 4849391, 4719565, 4751101, 4790766, 4774117, 4736129, 4895706, 4858370
Recalling Firm/
Manufacturer
ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact
949-366-2183
Manufacturer Reason
for Recall
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
FDA Determined
Cause 2
Process control
Action On 08/31/2020, Medical Device Recall notices were mailed to customers informing them to take the following actions: 1) Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if you do not have the affected product. 3) ICU Medical has some lots of unaffected product available today and is actively increasing the amount of available inventory. In the event specific product is unavailable, consider use of the non-spinning Spiros or the ChemoLock CSTD as alternatives. Please contact customer service for product availability. 4) Return affected product using the return label provided with this letter. Contact Stericycle at 1-888-871-7108 (MF, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product. 5) If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Stericycle to obtain a response form. For further inquiries, please contact: Global Complaint Management, 1-844-654-7780 or ProductComplaintsPP@icumed.com; Customer Service, 1-866-829-9025, option 8 or, customerservice@icumed.com, (M-F, 8am-6pm CT) On 10/07/2020, the Medical Device Recall notice, with an expanded affected device scope, was sent to customers.
Quantity in Commerce 19850
Distribution Worldwide distribution - U.S. Nationwide distribution including in the states of FL, MD, LA, PA, IN, TX, NY, MO, VA, OH, GA, NC, IL, CA, AZ, AK, NE, DE, WI, CO, UT, ND, MS, MA, MN, WA, SC, OR, KS, MI, NH, NJ, KY, TN, ID, AR, CT, OK, AL, SD, ME, IA, VT, WY, DC, NV, RI, MT, NM, HI, WV and the countries of Italy, Belgium, United Kingdom, Canada, Germany, Argentina, Australia, Poland, Greece, Switzerland, Israel, France, Finland, Spain, Malaysia, Taiwan, Ireland, Luxembourg, Hong Kong , Brazil, Netherlands, Austria, Sweden, Turkey, Singapore, Slovakia, Croatia, South Africa, Romania, Thailand.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = ICU MEDICAL, INC
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