Reference: FA (Peripheral Intervention) Expiration Date Range: March 31, 2012 to February 28, 2014 M M M
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1 Attachment A (Bilaga A) - Affected products (Berörda Produkter) Urgent Medical Device Recall (Angeläget Återkallande av Medicinsk produkt) Imager TM II Angiographic Catheter Reference: FA (Peripheral Intervention) Expiration Date Range: March 31, 2012 to February 28, 2014 Product Description Material (UPN) II/5/ST/65/038 M M II/5/ST/100/038 M M II/5/ST/65/035 BX 5 M M II/5/ST/100/035 BX 5 M M II/5/BARNH/100/038 M M II/5/BERN/100/038 M M II/5/BERN/100/035 BX 5 M M II/5/BERN/40/035 BX 5 II/5/BERN/40/038 M M M M Page 1/11 -
2 Material (UPN) II/5/ST/65/038 II/5/BERN/65/035 M M M M BX II/5/BERN/65/038 M M II/5/WEIN/100/038 M M II/5/WEIN/100/035 BX 5 M M II/5/H1/65/038 M M II/5/H1/100/038 M M II/5/H1/100/035 (SGL) M M S II/5/H1/100/035 BX 5 M M II/5/H3/100/038 M M II/5/H3/100/035 BX 5 M M II/5/H1H/100/038 M M II/5/H1H/100/035 BX 5 M M II/5/H3H/100/035 BX 5 M M II/5/JB1/65/038 M M II/5/JB1/100/038 M M II/5/JB1/100/035 BX 5 M M Page 2/11 -
3 Material (UPN) II/5/ST/65/038 II/5/JB2/100/038 M M M M II/5/JB2/100/035 BX 5 M M II/5/JB3/100/038 M M II/5/JB3/100/035 BX 5 M M II/5/MAN/100/038 M M II/5/MAN/100/035 BX 5 M M II/5/SIM1/65/038 M M II/5/SIM1/65/035 BX 5 M M II/5/SIM1/100/038 M M II/5/SIM1/100/035 BX 5 M M II/5/SIM2/100/038 M M II/5/SIM2/100/035 BX 5 M M II/5/SIM3/100/038 M M II/5/SIM3/100/035 BX 5 M M II/5/SIM4/100/038 M M II/5/HN1/100/038 M M II/5/HN1/100/035 BX 5 M M II/5/HN2/100/038 M M II/5/HN2/100/035 BX 5 M M II/5/HN3/100/038 M M II/5/HN3/100/035 BX 5 M M II/5/HN4/100/038 M M II/5/HN4/100/035 BX 5 M M II/5/HN5/100/038 M M II/5/HN5/100/035 BX 5 M M II/5/CK/100/035 BX 5 M M Page 3/11 -
4 Material (UPN) II/5/ST/65/038 II/5/GEN/100/035 BX 5 M M M M II/5/GEN+2 SIDEHOLES/100/035 BX 5 M M II/5/CHGB/65/038 M M II/5/CHGB/65/035 BX 5 M M II/5/CHGC/65/038 M M II/5/CHGC/65/035 BX 5 M M II/5/CHG2.5/65/038 M M II/5/CHG2.5/65/035 BX 5 M M II/5/CONTRA 2/65/038 II/5/CONTRA 2/65/035 BX II/5/DUCK/65/038 M M II/5/DUCK/65/035 BX 5 II/5/C1/65/038 M M M M II/5/C1/65/035 BX 5 M M II/5/C1+2 SIDE HOLES/65/038 M M II/5/C1+2 SIDE HOLES/65/035 BX 5 M M II/5/C2/65/038 M M II/5/C2/65/035 BX 5 M M M M M M Page 4/11 -
5 Material (UPN) II/5/ST/65/038 II/5/C2+2 SIDE M M M M HOLES/65/ II/5/C2+2 SIDE M M HOLES/65/035 BX II/5/C3/65/038 M M II/5/C3/65/035 BX 5 M M II/5/C3+2 SIDE HOLES/65/038 II/5/C3+2 SIDEHOLES/65/035 BX 5 II/5/VAN+2 SIDE HOLES/65/038 M M M M M M II/5/TRAIN/65/038 M M II/5/MIK/65/038 M M II/5/MIK/65/035 BX 5 M M II/5/HK1.0/65/038 M M II/5/HK1.0/65/035 BX 5 M M II/5/SHK0.8/65/038 M M II/5/SHK0.8/65/035 BX 5 M M II/5/SHK1.0/65/038 M M II/5/SHK1.0/65/035 BX 5 M M II/5/RC1/65/038 M M II/5/RC1/65/035 BX 5 M M II/5/RC2/65/038 M M II/5/RC2/65/035 BX 5 M M II/5/RDC/65/038 M M II/5/RDC/65/035 BX 5 M M Page 5/11 -
6 Material (UPN) II/5/ST/65/038 II/5/RDC+2 SIDE M M M M HOLES/65/ II/5/RDC+2 SIDEHOLES/65/035 BX 5 M M II/4/TENNIS RACQUET/65/035 II/4/TENNIS RACQUET/90/035 II/4/TENNIS RACQUET/100/035 II/5/TENNIS RACQUET/65/035 II/5/TENNIS RACQUET/90/035 II/5/TENNIS RACQUET/100/035 II/5/TENNIS RACQUET/65/038 II/5/TENNIS RACQUET/90/038 II/5/TENNIS RACQUET/100/038 II/4/PIGTAIL/65/035 II/4/STRAIGHT/65/035 II/4/PIGTAIL/90/035 M M M M M M M M M M M M M M M M M M M M M M M M II/4/STRAIGHT/ 90/035 M M S Page 6/11 -
7 Material (UPN) II/5/ST/65/038 II/4/STRAIGHT/90/035 M M M M II/5/PIGTAIL/65/038 M M II/5/PIGTAIL/90/038 M M II/5/PIGTAIL/100/038 M M II/5/STAIGHT/65/038 M M II/5/STAIGHT/90/038 M M II/5/STAIGHT/100/038 M M II/5/PIGTAIL/65/035 M M II/5/STRAIGHT/65/035 M M II/5/PIGTAIL/90/035 M M Page 7/11 -
8 Material (UPN) II/5/ST/65/038 II/5/STRAIGHT/90/035 M M M M II/5/PIGTAIL/100/035 M M S (SGL) II/5/PIGTAIL/100/035 M M II/5/STRAIGHT/100/035 M M M M II/4/CONTRALATERAL/65/ M M II/4/CONTRALATERAL/90/ M M II/4/CONTRALATERAL/100/ M M II/5/CONTRALATERAL/65/ M M II/5/CONTRALATERAL/90/ M M II/5/CONTRALATERAL/100/ M M II/5/CONTRALATERAL/65/ Page 8/11 -
9 Material (UPN) M II/5/ST/65/038 M M M II/5/CONTRALATERAL/90/ M M II/5/CONTRALATERAL/100/ ST/65/035 M M ST/100/035 M M M M BARNH/100/ M M BERN/100/ M M BERN/40/ M M BERN/65/ M M WEIN/100/ H1/65/035 M M H1/100/035 M M H3/100/035 M M H1H/100/035 M M JB1/65/035 M M JB1/100/035 M M JB2/100/035 M M Page 9/11 -
10 Material (UPN) MODEL- II/5/ST/65/038 4/ JB3/100/035 M M M M MAN/100/035 M M SIM1/65/035 M M SIM1/100/035 SIM2/100/035 SIM3/100/035 M M M M M M HN1/100/035 M M HN2/100/035 M M HN3/100/035 M M HN4/100/035 M M HN5/100/035 M M CK/100/035 M M GEN/2S/100/035 CHGB/65/035 CHGC/65/035 CHG2.5/65/035 CONTRA 2/65/035 DUCK/65/035 C1/65/035 MODEL- II/4/C1+2 SIDE HOLES/65/035 MODEL- II/4/C2+2 SIDE HOLES/65/035 M M M M M M M M M M M M M M M M M M C2/65/035 M M C3/65/035 M M Page 10/11 -
11 Material (UPN) MODEL- II/5/ST/65/038 II/4/C3+2 M M M M SIDEHOLES/65/035 MODEL- II/4/VAN+2 SIDEHOLES/65/035 TRAIN/65/035 M M M M MIK/65/035 M M HK1.0/65/035 SHK0.8/65/035 SHK1.0/65/035 M M M M M M RC1/65/035 M M RC2/65/035 M M RDC/65/035 M M MODEL- II/4/RDC +2 SIDEHOLES/65/035 M M Page 11/11 -
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