| Class 2 Device Recall MicroClave Clear Neutral Connector;MicroClave Clear Connector |  |
Date Initiated by Firm | August 01, 2022 |
Create Date | September 09, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1722-2022 |
Recall Event ID |
90726 |
510(K)Number | K970855 |
Product Classification |
Tube, feeding - Product Code FPD
|
Product | MicroClave Clear Neutral Connector;
MicroClave Clear Connector;
MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set |
Code Information |
Product Number: 011-MC100
UDI Code:
01108406190425061726120130100105737404
01108406190425061726120130100105740700
01108406190425061726120130100105740701
01108406190425061726120130100105740702
01108406190425061726120130100105740703
01108406190425061726120130100105740705
01108406190425061726120130100105740706
01108406190425061726120130100105740707
01108406190425061726120130100105740708
01108406190425061726120130100105740712
01108406190425061726120130100105740713
01108406190425061726120130100105740714
01108406190425061726120130100105740715
01108406190425061726120130100105740719
01108406190425061726120130100105740721
01108406190425061727010130100105793254
01108406190425061727010130100105793255
01108406190425061727010130100105793259
Lot Numbers:
5737404
5740700
5740701
5740702
5740703
5740705
5740706
5740707
5740708
5740712
5740713
5740714
5740715
5740719
5740721
5793254
5793255
5793259
Product Number: MR4001
UDI Codes:
01108877090796081726120130100105738132
Lot Numbers:
5738132
Product Number: MS984
UDI Code:
01108424721008291726120130100105737492
Lot Number
5737492
Product Number: SC3000
UDI Code:
01108877090818301726120130100105726857
01108877090818301726120130100105753967
Lot Number:
5726857
5753967
|
Recalling Firm/ Manufacturer |
ICU Medical, Inc. 951 Calle Amanecer San Clemente CA 92673-6212
|
For Additional Information Contact | Customer Service 868-829-9025 Ext. 8 |
Manufacturer Reason for Recall | Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. |
FDA Determined Cause 2 | Process control |
Action | On 08/01/2022, ICU Medical, Inc. communicated an "URGENT: MEDICAL DEVICE RECALL" Letter via certified mail to inform customers that a manufacturing defect has been identified which results in a visible gap between the MicroClave Clear connector's top and bottom housing. This defect may potentially cause or lead to delayed delivery of infusion solution during setup/infusion, fluid leak, blood loss/exposure to patient blood, air embolism, exposure to allergenic/caustic substances, or fluid path contamination.
Required Actions for Users:
1) Discontinue the use and distribution of the affected product immediately. Check inventory and quarantine all affected product at their facility.
ted product.
2) Return affected product using the return label provided with this letter. Contact Sedgwick at 1-888-965-5798 (MF, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product. The return labels are for single use only. Please do not reproduce. Please visit http://expertezlabel.com
to request additional labels for returning affected product. To ensure proper and timely credit, follow the instructions on the return label for returning product. Upon receipt of the completed response form and return of the affected product, ICU Medical will credit you for any product returned. You will only receive credit for product that you return. NOTE: Credits for product purchased through distributor will be credited by the distributor.
4) 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 Sedgwick at 1-888-965-5798 (M-F, 8am-5pm ET) to obtain a response form.
For questions - contact Customer Service 1-866-8295, option 8 or customerservice@icumed.com (M-F, 8am-6pm CT) |
Quantity in Commerce | Total of all affected units = 5,795,989 units |
Distribution | U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
O.U.S.: Austria, Bahrain, Belgium, Canada, Colombia, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
O.U.S. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = FPD
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