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EDMUND G. BROWN JR.
Governor

State of California—Health and Human Services Agency
California Department of Public Health


AFL 12-28
May 25, 2012


TO:
All Facilities

SUBJECT:
Curlin Intravenous (IV) Administration Sets: Recall Due to Possible Health Risk


The California Department of Public Health is advising all facilities to take the following actions based on an urgent message from the Food and Drug Administration (FDA):

Immediately discontinue use of Curlin IV Sets with the following REF (catalog) and lot numbers, which were sold and distributed between December 2011 and May 2012:

REF Codes (found in the top right hand corner of the administration set packaging):

340-4114 ​340-4126 ​340-4128-V ​340-4130-V ​340-4137 ​340-4165 ​340-4173
​340-4115 ​340-4128 ​340-4130 ​340-4133 ​340-4144​340-4166 ​340-4176

Lot Numbers (found in the lower right hand corner of the administration set packaging):

CF1127990 ​CF1132291 ​CF1200291 ​CF1201890 ​CF1204092 ​CF1206092
​CF1127991 ​CF1133490 ​CF1200292 ​CF1201891 ​CF1204093 ​CF1206890
​CF1127992 ​CF1133491 ​CF1200293 ​CF1201892 ​CF1204690 ​CF1206891
​CF1129990 ​CF1134390 ​CF1200294 ​CF1201893 ​CF1204691 ​CF1206893
​CF1130190 ​CF1134391 ​CF1200490 ​CF1202590 ​CF1204692 ​CF1207590
​CF1130690 ​CF1134392 ​CF1200491 ​CF1202591 ​CF1205490 ​CF1207591
​CF1130691 ​CF1134393​CF1200492 ​CF1202592 ​CF1205491 ​CF1207592
​CF1130692 ​CF1134990 ​CF1200493 ​CF1203390 ​CF1205492 ​CF1207593
​CF1130693 ​CF1135490 ​CF1200494 ​CF1203391 ​CF1205493 ​CF1208090
​CF1131190 ​CF1135491 ​CF1201190 ​CF1203392 ​CF1205990 ​CF1208091
​CF1131191 ​CF1135492 ​CF1201191 ​CF1204090 ​CF1206090 ​CF1208092
​CF1132290 ​CF1200290 ​CF1201192 ​CF1204091 ​CF1206091 ​CF1209091

 

The FDA advises that Moog Medical Devices Group (MMDG) has voluntarily issued a recall for these lots of Curlin IV Administration Sets, which have the potential to cause serious injury or death due to blood loss, under-delivery of prescribed medication/fluid, or a potential delay in therapy. The recall was initiated as a result of a customer-discovered

reverse pump segment. To date, customer complaints have identified three (3) out of 544,900 suspect sets manufactured for the United States. Despite the potential for reverse flow when using an affected set, MMDG has not received any reports of injury or death as a result of this issue. MMDG has identified and corrected the root cause by immediately initiating a supplier corrective action request and implementing additional preventative measures.

MMDG is working with the FDA to coordinate recall activities. Direct customers and distributors will be notified of the process for obtaining replacement administration sets by MMDG. For additional questions, contact Moog Customer Advocacy at (800) 970-2337.

Healthcare professionals and patients are encouraged to report any adverse events or side effects related to the use of these products to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Online: (https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm)

Regular mail: MedWatch
5600 Fishers Lane
Rockville, MD 20852-9787

Fax: 1-800-FDA-0178

For mail or fax reporting, please use FDA form 3500, available at the FDA website:

(https://www.fda.gov/safety/medwatch/howtoreport/downloadforms/default.htm) or by request by calling 1-800-332-1088.

Thank you for your prompt attention to this matter.

 

Sincerely,

Original Signed By Debby Rogers

Debby Rogers, RN, MS, FAEN
Deputy Director
Center for Health Care Quality

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