{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Reading",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73045",
      "recalling_firm": "Arrow International Inc",
      "address_1": "2400 Bernville Rd",
      "address_2": "N/A",
      "postal_code": "19605-9607",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including    AL  AR  AZ  CA  CO  CT  DE  FL  GA  IA  ID  IL  IN  KY  LA  MA  MD  MI  MN  MO  MS  MT  NC  ND  NE  NH  NJ  NM  NV  NY  OH  OK  OR  PA  RI  SC  TN  TX  UT  VA  VT  WA  WI  WV",
      "recall_number": "Z-1064-2016",
      "product_description": "Super Arrow-Flex Percutaneous Sheath Introducer Sets    REF CL-07035 or CL-07635 or CL-07735 or CL-07835  Super Arrow-Flex  Percutaneous Sheath Introducer Set  with Integral Hemostasis Valve/Side Port  and Radiopaque Tip Marker Band  Contents:  1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque  with Integral Hemostasis Valve/Side Port, 3-way Stopcock and Tissue Dilator  1: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Obturator: 8 Fr.  Rx only.    The Arrow Percutaneous Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.",
      "product_quantity": "56,521 units",
      "reason_for_recall": "Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur.",
      "recall_initiation_date": "20160112",
      "center_classification_date": "20160307",
      "termination_date": "20180226",
      "report_date": "20160316",
      "code_info": "Material number :CL-07035  Batch #'s: CF0045142  CF0087118  CF0090127  CF0128575  CF1022799  CF1034863  CF1046302  CF1060275  CF1083652  CF2019968  CF2021329  CF2045237  CF2056298  CF2092322  CF2125658  CF3031070  14F13G0157  14F13H0140  14F13K0108  14F13K0334  14F14A0435  14F14B0295  14F14C0449  14F14F0184  14F14F0282  14F14J0055  14F14L0126  14F15A0097  14F15A0473  14F15C0455  14F15C0455  14F15E0083  14F15E0392  14F15G0350  14F15L0009    Material #: CL-07635  Batch #'s: CF0014629  CF0016145  CF0026765  CF0027875  CF0029004  CF0031879  CF0043747  CF0044445  CF0045312  CF0046072  CF0057307  CF0058371  CF0058639  CF0059715  CF0060443  CF0061539  CF0062000  CF0062968  CF0074416  CF0074954  CF0086388  CF0088268  CF0098848  CF0099814  CF0090135  CF0090990  CF0104732  CF0115512  CF0115640  CF0117991  CF0128581  CF0129532  CF1022803  CF1022900  CF1023194  CF1035539  CF1046005  CF1046603  CF1057461  CF1058601  CF1069026  CF1069417  CF1071115  CF1071530  CF1082816  CF1083655  CF1084050  CF1094408  CF1095121  CF1095422  CF1106140  CF1106463  CF1106567  CF1106866  CF1117776  CF1118184  CF2010024  CF2010554  CF2011013  CF2021345  CF2021568  CF2022380  CF2032704  CF2033760  CF2044057  CF2044557  CF2044918  CF2055632  CF2055879  CF2067193  CF2067783  CF2068117  CF2078723  CF2079280  CF2079792  CF2079893  CF2080185  CF2080838  CF2081222  CF2114750  CF2115091  CF2125371  CF2125810  CF3016842  CF3017268  CF3017895  CF3018102  CF3028486  CF3028692  CF3029687  CF3030417  CF3031073  CF3041971  CF3064771  CF3065130  14F13G0058  14F13G0104  14F13G0229  14F13H0292  14F13H0421  14F13J0267  14F13K0066  14F13K0171  14F13L0012  14F13L0105  14F13M0040  14F14A0310  14F14A0420  14F14B0167  14F14B0309  14F14C0077  14F14C0191  14F14D0013  14F14D0155  14F14D0351  14F14D0373  14F14F0230  14F14F0284  14F14G0425  14F14H0028  14F14H0309  14F14J0021  14F14J0098  14F14J0336  14F14K0036  14F14K0099  14F14K0382  14F14L0352  14F14M0121  14F15A0234  14F15A0341  14F15B0076  14F15B0156  14F15B0372  14F15C0066  14F15D0009  14F15D0089  14F15D0183  14F15D0395  14F15E0180  14F15E0393  14F15F0177  14F15F0409  14F15G0052  14F15G0403  14F15H0237  14F15H0400  14F15H0442  14F15J0047  14F15J0128  14F15J0376  14F15K0480  14F15M0076    Material #: CL-07735  Batch #'s:  CF0016456  CF0026767  CF0027385  CF0028486  CF0031869  CF0043766  CF0045145  CF0046070  CF0057960  CF0059633  CF0060473  CF0062110  CF0063321  CF0074956  CF0087127  CF0088323  CF0090136  CF0102551  CF0104733  CF0115515  CF0117962  CF0128881  CF1010273  CF1022804  CF1023188  CF1034955  CF1035534  CF1046237  CF1057122  CF1057847  CF1069027  CF1069422  CF1060281  CF1071533  CF1084052  CF1094634  CF1105903  CF1106857  CF1118176  CF1129218  CF2010449  CF2011017  CF2032701  CF2033764  CF2044055  CF2044562  CF2055623  CF2055885  CF2067195  CF2068127  CF2078858  CF2079277  CF2079801  CF2079894  CF2080840  CF2125806  CF3017886  CF3018109  CF3028509  CF3028705  CF3039881  CF3030420  CF3031076  CF3041472  CF3052851  CF3065365  14F13G0062  14F13H0125  14F13H0221  14F13H0412  14F13J0045  14F13J0151  14F14A0132  14F14A0423  14F14A0309  14F14B0416  14F14C0323  14F14E0190  14F14E0288  14F14F0064  14F14F0185  14F14F0295  14F14J0323  14F14K0041  14F14K0336  14F14M0038  14F14M0103  14F15A0237  14F15B0022  14F15B0297  14F15B0383  14F15D0382  14F15E0072  14F15F0178  14F15H0347  14F15J0269  14F15K0186  14F15K0481    Material #: CL-07835  Batch #'s: CF0014633  CF0026778  CF0028429  CF0029002  CF0043169  CF0046789  CF0058376  CF0061314  CF0062035  CF0063323  CF0086389  CF0098907  CF0090978  CF0104735  CF0128583  CF1022800  CF1023680  CF1035526  CF1046612  CF1057118  CF1058023  CF1069009  CF1069427  CF1071067  CF1082806  CF1084066  CF1094643  CF1095413  CF1106147  CF1117143  CF2010674  CF2021578  CF2022383  CF2033430  CF2044046  CF2055624  CF2056307  CF2056890  CF2067792  CF2068581  CF2079137  CF2079794  CF2079908  CF2080524  CF3016368  CF3016852  CF3018112  CF3028508  CF3029318  CF3039885  CF3031078  CF3041826  CF3042524  CF3053165  CF3065135  14F13G0155  14F13H0127  14F13H0288  14F13J0038  14F13K0175  14F13L0070  14F13L0243  14F13M0045  14F14A0428  14F14B0161  14F14B0305  14F14C0105  14F14D0055  14F14F0116  14F14F0287  14F14G0466  14F14J0022  14F14J0326  14F14K0280  14F14L0068  14F15A0334  14F15A0334  14F15B0230  14F15B0367  14F15C0185  14F15F0282  14F15G0159  14F15G0470  14F15H0402  14F15K0482  14F15M0243"
    }
  ]
}