| Class 2 Device Recall MicroClave 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set |  |
Date Initiated by Firm | August 01, 2022 |
Create Date | September 09, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1720-2022 |
Recall Event ID |
90726 |
510(K)Number | K100576 |
Product Classification |
Set, administration, intravascular - Product Code FPA
|
Product | 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer; |
Code Information |
Product Number: 12517-01
UDI Code:
0110887709047201172612013050105735675
0110887709047201172612013050105755784
0110887709047201172612013050105755788
0110887709047201172702013050105812525
Lot Numbers:
5735675
5755784
5755788
5812525
Product Number: A1099
UDI Codes:
0110887709053127172611013050105692378
Lot Numbers:
5692378
Product Number: A1129
UDI Code:
0110887709068190172612013050105755485
0110887709068190172701013050105772087
Lot Number
5755485
5772087
Product Number: A1132
UDI Code:
0110887709068350172701013050105772482
Lot Number:
5772482
Product Number: A1152
UDI Code:
0110887709071527172612013050105735432
0110887709071527172701013050105787700
Lot Number:
5735432
5787700
Product Number: MC330113
UDI Codes:
0110887709078120172612013050105746371
0110887709078120172612013050105755711
0110887709078120172701013050105789359
Lot Numbers:
5746371
5755711
5789359
Product Number: MC330246
UDI Codes:
0110887709081502172610013050105641882
0110887709081502172612013050105738474
0110887709081502172701013050105773798
0110887709081502172701013050105788509
0110887709081502172701013050105809713
Lot Numbers:
5641882
5738474
5773798
5788509
5809713
Product Number: MC330247
UDI Codes:
0110887709081519172612013050105745619
0110887709081519172612013050105756766
0110887709081519172701013050105777168
0110887709081519172701013050105789411
Lot Numbers:
5745619
5756766
5777168
5789411
Product Number: MC33056
UDI Code:
0110887709037301172701013050105772683
Lot Number:
5772683
Product Number: MC330605
UDI Code:
0110887709097008172701013050105789539
Lot Number:
5789539
Product Number: MC33122
UDI Codes:
0110887709037400172612013050105757061
0110887709037400172701013050105772640
0110887709037400172701013050105788745
Lot Numbers:
5757061
5772640
5788745
Product Number: MC33213
UDI Codes:
0110887709037516172612013050105736601
0110887709037516172701013050105789780
0110887709037516172701013050105789784
Lot Numbers:
5736601
5789780
5789784
Product Number: MC33326
UDI Codes:
0110887709037752172612013050105757376
0110887709037752172701013050105772627
0110887709037752172701013050105772638
0110887709037752172702013050105810377
Lot Numbers:
5757376
5772627
5772638
5810377
Product Number: MC33600
UDI Code:
0110887709051932172701013050105789950
Lot Number:
5789950
Product Number: MC33729
UDI Codes:
0110887709065045172701013050105789984
0110887709065045172701013050105800993
Lot Numbers:
5789984
5800993
Product Number: MC33786
UDI Code:
0110887709067551172701013050105778247
Lot Number:
5778247
Product Number: Z3419
UDI Code:
0110887709032108172612013050105754551
Lot Number:
5754551
Product Number: Z3678
UDI Codes:
0110887709034607172612013050105754702
0110887709034607172701013050105777801
Lot Numbers:
5754702
5777801
|
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 = FPA
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